A Study of Cerebral Perfusion With tDCS in Chronic Hypoperfusion - Not yet recruiting

This study is being done to examine whether transcranial direct current stimulation (tDCS) will increase cerebral blood flow in subject's diagnosed with Moyamoya disease or severe extracranial atherosclerotic disease, which may provide a clinical benefit such as improving cognitive impairment.

Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation (NIBS4CIPN) - Not yet recruiting

Over half of cancer patients receiving common chemotherapy treatments experience painful nerve damage called chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients are more likely to suffer from this condition and more often need to reduce their chemotherapy doses compared to Non-Hispanic White (NHW) patients. This research aims to conduct a study to test if tDCS is a helpful treatment for painful CIPN, investigate how CIPN affects brain function in NHB and NHW patients, and examine the role of inflammation in CIPN and its connection to pain severity and brain function.

Extending taVNS Paired With Infant CIMT Into a Home-Based Setting - Completed

Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called constraint-induced movement therapy (CIMT). Even with the high intensity therapy of CIMT, it typically takes between 40-120 hours total treatment time for most children to improve their motor skills. A non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), stimulates a nerve by the ear that enhances learning motor skills. taVNS stimulation will be triggered by EMG sensors which detect muscle activity. The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with CIMT in infants with one-sided weakness at 6-18 months of age.

Sponsor
Medical University of South Carolina

Complete information at Clinical Trials.Gov

A custom version of the Soterix Medical taVNS device is being used in this study. The standard Soterix Medical taVNS system provides the necessary pulse parameter settings (frequency, train duration, inter-train interval, session duration) that allow testing commonly used protocols. With the option to unlock devices in as many as three different ways (code-based , time-based, ElectraRx web-based), the system provides researchers with flexibility to plan taVNS trials as they wish.

Selected References

Transcutaneous Vagus Nerve Stimulation (tVNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial (cMPsE02). Bauer S, Baier H, Baumgartner C, Bohlmann K, Fauser S, Graf W, Hillenbrand B, Hirsch M, Last C, Lerche H, Mayer T, Schulze-Bonhage A, Steinhoff BJ, Weber Y, Hartlep A, Rosenow F, Hamer HM. 2016 May-Jun;9(3):356-363.
Transcutaneous Vagus Nerve Stimulation (tVNS) Enhances Response Selection During Sequential Action. Jongkees BJ, Immink MA, Finisguerra A, Colzato LS. Front Psychol. 2018 Jul 6;9:1159.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge - Recruiting

Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days.

Sponsor
Medical University of South Carolina

Complete information at Clinical Trials.Gov

Selected References

Transcutaneous Vagus Nerve Stimulation (tVNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial (cMPsE02). Bauer S, Baier H, Baumgartner C, Bohlmann K, Fauser S, Graf W, Hillenbrand B, Hirsch M, Last C, Lerche H, Mayer T, Schulze-Bonhage A, Steinhoff BJ, Weber Y, Hartlep A, Rosenow F, Hamer HM. Brain Stimul. 2016 May-Jun;9(3):356-363.
Transcutaneous Vagus Nerve Stimulation (tVNS) Enhances Response Selection During Sequential Action. Jongkees BJ, Immink MA, Finisguerra A, Colzato LS. Front Psychol. 2018 Jul 6;9:1159.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Using tDCS in Speech-based Stroke Rehabilitation - Recruiting

The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Transcranial direct current stimulation (tDCS), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tDCS provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. This will be examined with a series of single-case experimental designs.

Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training - Completed

The purpose of this study is to test the influences of transcranial direct current stimulation (tDCS) on the acquisition of laparoscopic surgical skills. For this purpose, the investigator will compare variants of tDCS in the first of 2 experiments. The second arm of the trial will investigate gaze training in a similar study design. These questions will be evaluated using the validated Fundamentals of Laparoscopic Surgery (FLS) module 1, with the overall goal of developing a surgical training curriculum that achieves expert level skill in an expedited timeframe. This research provides a novel approach to general surgery training that has the potential to reduce the amount of time and repetitions required to achieve expert laparoscopic skills.

Sponsor
Duke University

Complete information at Clinical Trials.Gov

The Soterix Medical 1X1 tDCS device is being used in the study. The Soterix Medical 1x1 is the clinical standard device when precision and safety cannot be compromised. The Open-Panel™ control panel allows simple set-up and monitoring. Exclusive features including SmartScan™, RELAX™, and TrueCurrent™ ensure every run is successful. - tDCS.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Neuromodulation of Cognition in Older Adults - Completed

This study will investigate whether transcranial direct current stimulation enhances the effects of cognitive training in healthy older adults.

Sponsor
University of Florida

Collaborator
National Institute on Aging (NIA)
National Center for Advancing Translational Sciences (NCATS)

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Accelerating Motor Learning in Pediatrics (AMPED) - Completed

The purpose of this research is to see if two different types of tDCS can improve motor function in healthy children. tDCS has been shown to safely enhance hand motor function in healthy adults, and those that have suffered stroke and other conditions. Recently the investigators demonstrated that tDCS may enhance hand motor function in healthy children, however, how it does so is unknown. In addition to assessing changes in motor function when tDCS is given during motor skill training, the investigators will perform various tests before and after stimulation to understand the changes that happen in the brain accompanying motor skill learning and brain stimulation.

Sponsor
University of Calgary

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain - Completed

This study investigates comparing the effects of transcranial Pulsed Current Stimulation and transcranial Direct Current Stimulation (tDCS) and their combination on neurophysiological outcomes on healthy subjects as well as on the clinical population for chronic visceral pain. The study also aims to evaluate the effects of these techniques on pain thresholds in healthy subjects as well as for chronic visceral pain patients.

Sponsor
Spaulding Rehabilitation Hospital

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS) - Active, Not Recruiting

This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT; active tDCS and sham MT (which consists of using a covered mirror for the therapy); and both sham tDCS and sham MT (covered mirror).

Sponsor
Spaulding Rehabilitation Hospital

Collaborator
Massachusetts Eye and Ear Infirmary

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

TDCS for Cocaine Addiction Craving - Completed

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In the present study, tDCS will be administered with the goal of assessing the tolerability and feasibility of this approach to 1) reduce an individual's level of drug craving and 2) provide evidence to support the use of this device by the patient for future unsupervised stimulation in a non-clinical setting.

Sponsor
Soterix Medical

Collaborator
Icahn School of Medicine at Mount Sinai

Complete information at Clinical Trials.Gov

The Soterix Medical 1X1 mini-CT device is being used in the study. The mini-CT provides unmatched controlled and reliability in conducting tDCS or tES trials in deployed environments without compromising dose precision and safety. - mini-CT.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Combining tDCS and Neurorehabilitation to Treat Age-related Deficits of Mobility and Cognition: UPfront Walking Study - Completed

Loss of mobility and cognitive ability are serious conditions that threaten the independence of older adults. The objective of this study is to initiate a line of research to develop a novel therapeutic intervention to enhance both mobility and cognition via neuroplasticity of frontal/executive circuits.

Sponsor
University of Florida

Collaborator
National Institute on Aging (NIA)

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation for Post-stroke Fatigue - Recruiting

The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.

Sponsor
Weill Medical College of Cornell University

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy - Completed

The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tDCS), a noninvasive brain stimulation technique, when delivered in combination with Written Exposure Therapy (WET), for posttraumatic stress disorder (PTSD).

More on Post Traumatic Stress Disorder (PTSD

Sponsor
The University of Texas Health Science Center at San Antonio

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Stimulation for Physiotherapy Optimisation - Chronic Low Back Pain (STOP-CLBP) - Recruiting

The main objective of this study is to investigate the effects of non-invasive brain stimulation (the so-called transcranial direct current stimulation ; tDCS) combined with an active physiotherapy program on the multidimensional impact of pain in patients with Chronic Low Back Pain (CLBP). The secondary objectives are to compare the effects of these interventions on fear of movement, psycho-emotional state, function, functional connectivity of the left dorsolaterla prefrontal cortex (DLPFC) and erector spinae activity.

Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis - Completed

The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).

Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis - Completed

This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.

Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation - Recruiting

The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.

Sponsor
University of Manitoba

Collaborator
Winnipeg Foundation

Complete information at Clinical Trials.Gov

The Soterix Medical MxN device is being used in the study. The MxN is part of the exclusive High-Definition platform which provides researchers with unprecedented targeted stimulation of neuronal structures.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Amplitude Titration to Improve ECT Clinical Outcomes - Recruiting

A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total).

Pain Relief for OsteoArthritis Through Combined Treatment (PROACT) - Recruiting

This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic whites with knee osteoarthritis (OA). This approach will provide evidence that targeting stress and pain-related brain function will reduce OA-related pain and ethnic group differences therein.

Electrical Neuromodulation for Focal Epilepsy - Not yet recruiting

The purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects.

Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA) - Completed

The purpose of this study is to establish the feasibility of a program of remotely supervised transcranial direct current stimulation (RS-tDCS) paired with language skills practice for people living with the semantic or logopenic variants of primary progressive aphasia (PPA). There are currently no established standard-of-care treatments for PPA. This study will evaluate whether RS-tDCS combined with language skills practice is a feasible study design for individuals with PPA.

Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset - Recruiting

The purposes of this research are to investigate (1) if schizophrenia patients and at-risk individuals present bradykinesia and dyskinesia and (2) if tDCS improves motor performance in schizophrenia patients and at-risk individuals. The first hypothesis is that both schizophrenia patients and at-risk individuals show bradykinesia and dyskinesia, and the motor symptoms are more severe in the former than the latter. The second hypothesis is that tDCS improves motor performance in schizophrenia patients and at-risk cases.

Stimulation for Perinatal Stroke Optimizing Recovery Trajectories (SPORT) - Completed

Perinatal stroke causes lifelong neurological disability and most hemiparetic cerebral palsy (CP). With morbidity spanning diverse aspects of a child's life and lasting for decades, global impact is large, including 10000 Canadian children. With pathophysiology poorly understood and prevention strategies non-existent, the burden of hemiparetic CP will persist. Limited treatments lead to loss of hope for children and families, necessitating exploration of new therapies. The investigators have evidence that the investigators have a durable new treatment for perinatal stroke, combining non-invasive neurostimulation and child-centred intensive rehabilitation. Via the CHILD-BRIGHT SPOR national network, the investigators will execute a multicentre trial to prove this treatment can improve function in children with perinatal stroke and hemiparetic CP.

Transcranial Direct Current Stimulation (tDCS) Therapy in Major Depression - Completed

Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to reduce symptoms in some people with major depressive disorder (MDD), the extent of antidepressant response often differs. Methods that map current flow directly in the brain while a person is receiving tDCS and that determine how functional neuroimaging signal changes after a series of tDCS sessions may help us understand how tDCS works, how it can be optimized, and if it can be used as an effective antidepressant. Investigators will address these questions in a two-part randomized double blind exploratory clinical trial. For this part of the study, investigators will determine relationships between target engagement and clinical outcomes (mood) and functional sub-constructs of cognitive control and emotion negativity bias, and whether imaging markers at baseline predict changes in antidepressant response.

More on Major Depressive Disorder

Sponsor
University of California, Los Angeles

Collaborator
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

HD-tDCS as a Treatment for Chronic Tinnitus - Completed

Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). The objective of the current study is to investigate the effect of HD-tDCS on tinnitus in a large patient cohort.

Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults - Completed

This study aims to evaluate the effect of noninvasive brain stimulation in adults with ADHD symptomatology compared them with healthy adults. For this, volunteers will allocate into two groups (experimental and control), will pass through session two types of transcranial stimulation: Repetitive Transcranial MagneticsStimulation (rTMS) and transcranial direct current stimulation (tDCS); considering two session types (real and sham). Attentional assessment will be carried out through specific neurocognitive tests applied before and after each session of stimulation.

Speech and Voice Outcomes Following HD-tDCS Over the Left SMA - Not yet recruiting

Pharmaceutical and neurosurgical treatments reliably ameliorate the cardinal motor symptoms in Parkinson's Disease (PD) but, they often yield inconsistent outcomes for speech and voice disorders, with some studies showing exacerbation of pre-treatment deficits. Therefore, it is crucial to develop and optimize novel approaches that could simultaneously improve speech and voice deficits in PD and facilitate existing behavioral interventions. This project will investigate the immediate and short-term effects of multiple sessions of HD-tDCS over the left SMA on speech and voice deficits in PD.

Transcranial Direct Current Stimulation (tDCS) Augments the Effects of Gamified, Mobile Attention Bias Modification - Completed

The present study tested whether transcranial direct current stimulation (tDCS) across the prefrontal cortex (PFC), versus sham stimulation, effectively augments the beneficial effects of a gamified attention bias modification training (ABMT) mobile app.

Sponsor
Hunter College of City University of New York

Collaborator
The City College of New York

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) - Recruiting

The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.

Transcranial Direct Current Stimulation for Gait Recovery Following Stroke (TransGait) - Recruiting

Stroke is a leading cause of adult disability. The ability to walk is considered as the most important physical activity in daily life and strongly associated with quality of life in patients with stroke sequela. The clinical and neurophysiological effects of High-definition transcranial Direct Current Stimulation (HD-tDCS) remain largely unknown for enhancing gait recovery in patients with stroke. The investigators hypothesize that anodal HD-tDCS will enhance neural interactions between motor networks and, thereby, improve motor processing and gait relearning. The investigators propose to carry out a study on chronic stroke patients involving anodal HD-tDCS of the affected primary motor cortex combined with a physical therapy.

More on Stroke

Sponsor
School of Health Sciences Geneva

Collaborator
University Hospital, Geneva

Complete information at Clinical Trials.Gov

The Soterix Medical 1X1 mini-CT device and 4x1 HD-tDCS/HD-tES Adapter will be used in this study. The mini-CT provides unmatched controlled and reliability in conducting tDCS or tES trials in deployed environments without compromising dose precision and safety. The Soterix 4×1 HD-tDCS adaptor converts any 2-channel tDCS stimulator into an HD-tDCS device. The 4×1 HD-tDCS adaptor is not a stand-alone stimulator, and during stimulation does not generate any current. Rather, the 4×1 HD-tDCS adaptor intelligently divides and guides current generated by a 2-channel device, converting it to HD-tDCS. The Soterix 4×1 HD-tDCS adaptor is thus an ideal solution where an existing 2-channel device is already in use.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Trial of Enhanced Neurostimulation for Anorexia (TRENA) - Recruiting

Preliminary open-label studies have suggested that non-invasive brain stimulation methods of both transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) have clinical benefits for improving psychological and eating disorder related symptoms, which can persist at long-term follow ups after acute treatment (i.e., at 6 and 12 months). Here the investigators propose to conduct the first double-blinded, randomised sham-controlled study to directly compare the therapeutic effectiveness and acceptability of both treatment modalities.

Electroconvulsive Therapy Amplitude Titration - Completed

This study is focused on advancing ECT treatment for older adults with depressive disorders by refining neuromodulation stimulus parameters to improve efficacy and cognitive safety.

More on Major Depressive Disorder

Sponsor
University of New Mexico

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa - Recruiting

The main goal of the study (a 3-week, randomized, double-blind, and placebo-controlled study) is to determine the effect of Transcranial Direct Current Stimulation (tDCS) on the mental state and advances in nutritional rehabilitation in patients with Anorexia Nervosa (AN). The primary hypothesis assumes that tDCS will reduce the symptoms of depression, improve cognition functions and it will have a positive effect on the reduction of restriction related to body weight and diet.

Effect of Speech Therapy in Combination With Non-invasive Brain Stimulation on Speech of Patients With Parkinson's Disease - Recruiting

Up to 90% of patients with Parkinson's disease (PD) have hypokinetic dysarthria (HD) in the early phase of the illness. HD is characterized by a harsh breathy voice quality, reduced variability of pitch and loudness and imprecise articulation. This project investigates the novel combination of speech therapy and home-based non-invasive brain stimulation (tDCS) treatment in order to increase overall positive effects on HD in PD. Using a novel multimodal analysis approach based on functional magnetic resonance and acoustic signal processing, we will be able to monitor changes in different domains of speech, as well as associated changes in brain plasticity.

Transcranial Alternating Current Stimulation (tACS) for the Recovery of Phonological Short-Term Memory in Patients With Aphasia After Stroke - Recruiting

This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke. It will employ high-definition tACS (HD-tACS) in a parallel, double-blinded, sham-controlled design combined with language therapy targeting phonological short-term memory (STM) function in stroke survivors with aphasia.

More on Stroke

Sponsor
Medical College of Wisconsin

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

tDCS and Glucose Uptake in Leg Muscles - Completed

This study is to examine the efficacy of tDCS in improving walking in people with Multiple Sclerosis (PwMS).

Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias - Completed

The purpose of this project is to evaluate the preliminary effects of home-based M1-SO applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain management in persons with early-stage AD.

More on Alzheimer's Disease and Related Dimentias

Sponsor
Florida State University

Collaborator
National Institute of Nursing Research (NINR)

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

HD-tDCS to Modulate Connectivity - Recruiting

The purpose of the proposed study is to broaden our understanding on the neural effects of High Definition Transcranial Direct Current Stimulation (HD-tDCS) so that its clinical effects can be further improved. Normal healthy individuals will be recruited and undergo a standardized neuropsychological assessment (ANAM, MoCA, BDI-II, ToMS, and MAAS) and magnetic resonance imaging (MRI). During MRI, HD-tDCS will be applied. Four different stimulation targets will be investigated, and subjects will be randomly assigned for each target groups or sham group. After HD-tDCS/MRI session, subjects will be re-assessed with standardized neuropsychological tests.

Sponsor
University of Manitoba

Collaborator
Natural Sciences and Engineering Research Council, Canada

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Altering Multitasking Behavior Using Low Current Brain Stimulation - Active, Not Recruiting

This study is designed to investigate multitasking deficits, with a particular interest in reducing costs related to dual-tasking (dividing attention between tasks) and task-switching (switching between tasks) using noninvasive brain stimulation.

Sponsor
Tufts University

Complete information at Clinical Trials.Gov

The Soterix Medical 1X1 tES device is being used in the study. The Soterix Medical 1x1 transcranial Electrical Stimulation (1x1-tES) device is the most sophisticated and precise stimulator ever designed for tDCS, tACS, tPCS, and tRNS. The 1x1 tES represents a decade of biomedical and industrial design to create a device that combines unmatched flexibility, reliability, and easy-of-use through unique Soterix Medical features and the Open-Panel™ interface.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

HD-tDCS for Phonological Impairment in Aphasia - Completed

This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery. Patients will be randomly assigned to one of 2 speech therapy groups as well as randomly assigned to one of 2 stimulation groups (active anodal stimulation or sham). Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted anodal-tDCS or sham-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to receive the tDCS intervention again, along with the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.

More on Aphasia

Sponsor
Medical College of Wisconsin

Complete information at Clinical Trials.Gov

The Soterix Medical 1X1 tES device and 4x1 HD-tDCS/HD-tES Adapter will be used in this study. The Soterix Medical 1x1 transcranial Electrical Stimulation (1x1-tES) device is the most sophisticated and precise stimulator ever designed for tDCS, tACS, tPCS, and tRNS. The 1x1 tES represents a decade of biomedical and industrial design to create a device that combines unmatched flexibility, reliability, and easy-of-use through unique Soterix Medical features and the Open-Panel™ interface. The Soterix 4×1 HD-tDCS adaptor converts any 2-channel tDCS stimulator into an HD-tDCS device. The 4×1 HD-tDCS adaptor is not a stand-alone stimulator, and during stimulation does not generate any current. Rather, the 4×1 HD-tDCS adaptor intelligently divides and guides current generated by a 2-channel device, converting it to HD-tDCS. The Soterix 4×1 HD-tDCS adaptor is thus an ideal solution where an existing 2-channel device is already in use.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis - Completed

The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis (OA).

Treatment of COVID-19 Post-acute Cognitive Impairment Sequelae With tDCS (PASC) - Completed

After almost 2 years of pandemic, the consequences of the post-COVID syndrome, or PASC (Post Acute-Sequelae of Sars-CoV-2), have become a major challenge in the management of affected patients, generating costs for health services, and insecurity regarding treatments for the sequelae, given the complex and still poorly understood pathophysiology of COVID-19. The objective of this double-blind randomized clinical trial is to assess whether tDCS associated with cognitive training can improve symptoms in patients with persistent cognitive deficits that started between 1 and 6 months after the resolution of acute COVID-19 infection (PASC) compared to the sham (placebo) group, in addition to exploring the structural, microstructural, functional and modeled electric field changes associated with cognitive alterations due to PASC syndrome and tDCS combined with cognitive treatment.

AMPLIFY Study: Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After SCI - Recruiting

Locomotor training (LT) facilitates recovery of spinal locomotor networks after incomplete spinal cord injury (ISCI), but walking impairments persist. A limitation of LT is insufficient excitation of spinal locomotor circuits to induce neuroplastic recovery. Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive approach to increase spinal excitation and modulate spinal reflexes. The study will examine if tsDCS combined with LT enhances locomotor rehabilitation after ISCI.

The Use of Transcranial Direct Current Stimulation (tDCS) in Adults With Developmental Disabilities (tDCS-RIADD) - Recruiting

Aggressive behaviours are highly prevalent among people with developmental disabilities, both in community and inpatient or residential settings, with adverse consequences for the individuals involved and others. Some predictive factors, particularly impulsivity, are dynamic with neurobiological underpinnings, and as such amenable to change or neuromodulation using non-invasive brain stimulation techniques. This study aims to assess the efficacy of anodal tDCS in modulating Rapid Response Impulsivity (RRI) and reducing incidents of aggression in people with developmental disabilities inn residential or hospital settings. Using a single blind, parallel arms, randomized controlled trial design, adults (n=60) aged 18 to 65 with developmental disabilities, who have a history of impulsivity leading to aggression, will be randomised to receive either repetitive anodal or sham tDCS. Enrolled participants will receive either three treatment sessions of tDCS or sham tDCS. Behavioural and impulsivity will be measured before and immediately after treatment, one week, and one month after treatment end.

Rapid Acting Transcranial Magnetic Stimulation - Recruiting

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind, randomized, sham-controlled fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.

More on Major Depressive Disorder

Sponsor
Stanford University

Complete information at Clinical Trials.Gov

The Soterix Medical Neural Navigator neuronavigation system is used in this study. The Neural Navigator provides unmatched precision in positioning the TMS coil over a specified target based on an individual’s MRI.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

taVNS for Persistent Symptoms From Lyme Disease - Active, Not recruiting

This study is one of the first studies to investigate a non-antibiotic approach to the treatment of symptoms that persist after antibiotic treatment for Lyme disease (PTLS). Transcutaneous auricular vagus nerve stimulation (taVNS) offers the potential of being an effective and non-toxic approach to reduce the burden of multisystem symptoms in patients with PTLS. This study seeks to address an important goal: to assess the safety, feasibility, and tolerability of a new non-invasive, non-pharmacologic treatment for patients with symptoms that persist despite prior antibiotic treatment for Lyme disease.

HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults - Completed

Sponsor
University of Florida

Collaborator
National Institute on Aging (NIA)

Complete information at Clinical Trials.Gov

The Soterix Medical transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system is being used in the study. The Soterix Medical 1x1- CT is the most advanced and customizable stimulation for true double-blind control trials. Each 1x1-CT unit is configured to a specific trial or set of trials, to ensure the highest standards of reproducibility and safety, all without breaking subject’s or operator’s blind.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Effects of Transcranial Direct Current Stimulation (tDCS) on Language - Recruiting

More on Aphasia

Sponsor
Medical College of Wisconsin

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation for Improving Gait Training in Stroke - Completed

The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with assisted gait training is effective for improving gait in patients with chronic stroke.

More on Stroke

Sponsor
University of Arkansas

Collaborator
University of Central Arkansas

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty - Completed

The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative transcranial Direct Current Stimulation (tDCS) + mindfulness-based intervention (MBI) in older adults (50+) undergoing total knee replacement (TKR). And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.

tDCS to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis - Completed

The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on neuropathic pain and fatigue in people with MS. The investigators will conduct tDCS or sham on 5 consecutive days. They will evaluate pain and fatigue with specific questionnaires and measure fatigability with an isokinetic device. The research question is whether tDCS can lessen neuropathic pain and increase fatigue resistance in people with MS. It is hypothesized, that less neuropathic pain and increased fatigue resistance after the tDCS sessions.

Tolerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors (TOPSS) - Completed

The purpose of this study is to evaluate the tolerability of tDCS in childhood stroke survivors and to assess for improvement in arm function in patients receiving tDCS and occupational therapy.

Cognitive Enhancement in Depression (The COG-D Study) - Recruiting

The purpose of this study is to determine whether the addition of active tDCS to computerized cognitive remediation (nCCR) enhances brain activity and cognitive functions in older adults with recurrent depression to a greater degree than nCCR with sham stimulation. The investigators will randomize 20 elderly depressed outpatients to either double-blinded active or sham bifrontal tDCS plus daily nCCR over 4-weeks. Multimodal MRI (focused on the cognitive control network; CCN) and psychiatric and neuropsychological evaluations will be obtained at baseline and following intervention completion. Long-term CCN cognitive effects will be explored 3-months post-intervention via cognitive assessments.

More on Major Depressive Disorder

Sponsor
Vanderbilt University Medical Center

Collaborator
American Academy of Neurology

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy - Completed

This study evaluates the effects of corticosteroid injections over time, as well as the additional effect provided by subsequent transcranial direct current stimulation (tDCS) of the motor cortex on patients with rotator cuff tendinopathy of the shoulder. All patients will receive a subacromial corticosteroid injection. Two weeks later, a third will receive a treatment of tDCS, a third will receive a placebo a-tDCS treatment, and the last third will not receive any additional treatment.

Sponsor
Université de Sherbrooke

Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Treatment Outcomes With tDCS in Post-Stroke Aphasia - Recruiting

The purpose this study is to test the utility of pairing external neuromodulation with behavioral language treatment to boost therapy outcomes and to investigate the mechanisms associated with recovery. Because all PWA have word retrieval deficits, this project will test if greater language gains can be achieved by supplementing anomia intervention with excitatory brain stimulation to the left hemisphere and will evaluate associated functional brain changes to aid the optimization of neural reorganization to facilitate language processing.

More on Aphasia

Sponsor
University of Arkansas

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Alternating Current Stimulation in Patients With Disorders of Consciousness - Recruiting

tACS is a transcranial nerve regulation technique ,it has been applied in depression, schizophrenia, dementia and other fields. However, the exact mechanism of tACS has not been fully elucidated, and there are few reports about the effect of tACS stimulation on patients with consciousness disorder at home and abroad. The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of HD-tACS in patients with chronic disorders of consciousness.

Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia - Completed

The goal of this clinical trial is to examine whether transcranial direct current stimulation(tDCS) can enhance the effect of virtual reality exposure therapy(VRET) in acrophobia in college students with significant fear of heights.

Home-Based tDCS in Children With ADHD: A Randomized, Sham-Controlled tDCS and fNIRS Study - Unknow Status

The purpose of this study is to investigate the efficacy of twenty daily sessions of home-based tDCS over the left DLPFC, right IFG on attention and response inhibition in children with ADHD. Investigators hypothesize that multiple sessions of tDCS will induce a greater and long-term effect on attentional and/or inhibitory response in children with ADHD. In addition, this study seeks to get a better understanding of the mechanisms of tDCS using fNIRS.

Non-invasive Neustimulation and Respiratory Rehabilitation - Recruiting

The objective of this study is to identify the chronic effects of non-invasive neurostimulation associated with the rehabilitation of patients with respiratory disorders. Material and methods: This is a pilot study, quantitative, clinical trial type, randomized and controlled, double blind. The sample will be composed of patients with respiratory diseases, aged above 18 years old. The study will consist of two groups: (1) HD-tDCS will be applied - anodic current + respiratory rehabilitation with respiratory muscle training (RMT) and (2) Sham - Only respiratory rehabilitation with RMT without any type of cortical stimulation. The chronic effects of neurostimulation by HD-tDCS associated with cardiopulmonary rehabilitation, with TMR, during 12 sessions will be evaluated.

Sponsor
Federal University of Paraíba, Suellen Andrade

Complete information at Clinical Trials.Gov

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Barriers to Substance Use Disorder Recovery - Completed

The study purpose is to investigate how an inpatient recovery coaching intervention can overcome or mitigate specific risk factors and barriers to initiating and maintaining Substance Use Disorder recovery. This study will offer insight into how and why an inpatient link to recovery coaching is effective for promoting long-term Substance Use Disorder recovery.

INSIGHT, A Comprehensive, Multidisciplinary Brain Training System (INSIGHT) - Completed

Recent innovations in cognitive neuroscience have advanced understanding of the neurobiological foundations of fluid intelligence (Gf) and adaptive reasoning and problem solving (ARP). Rather than engaging a single brain structure (e.g., prefrontal cortex) or operating at a fixed level of performance throughout adulthood, emerging neuroscience evidence indicates that Gf and ARP are mediated by a distributed neural system whose functions can be significantly enhanced by specific types of interventions, including cognitive training, high-definition transcranial direct-current brain stimulation (HD-tDCS), and physical fitness training. The main objective of the INSIGHT project is to establish and validate a comprehensive and rigorous brain training protocol that incorporates the best available interventions for the enhancement of Gf and ARP.

Sponsor
University of Illinois at Urbana-Champaign

Collaborator
The City College of New York
Aptima, Inc.
Georgia Institute of Technology
Circinnus LLC
Autonomous University of Madrid, Spain

Complete information at Clinical Trials.Gov

A Soterix Medical 2x2 HD-tDCS stimulator was used in this study. - 2x2 HD-tDCS

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Post-stroke Fatigue, Inflammation, tDCS - Completed

Fatigue is a common condition after an individual has a stroke. While the negative impacts of post-stroke fatigue are well known, the knowledge of the causes of post-stroke fatigue and effective treatments for post-stroke fatigue are lacking. This small study will investigate the possible benefits of transcranial direct current stimulation (tDCS), which uses small electrical currents supplied by a 9-volt battery, on post-stroke fatigue and investigate tDCS' possible anti-inflammatory effects.

Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation - Recruiting

Mania is a core symptom of bipolar disorder involving periods of euphoria. Current drug therapies for mania are frequently intolerable, ineffective, and carry significant risk for side effects. Presently there are no neurobiologically informed therapies that treat or prevent mania. However, using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions having a causal role in the development of mania in people without a psychiatric history can occur in different brain locations, such as the right orbitofrontal cortex (OFC), right dorsolateral prefrontal cortex (DLPFC), and right inferior temporal gyrus (ITG). This lesion network evidence converges with existing cross-sectional and longitudinal observations in bipolar mania that have identified specific disruptions in network communication between the amygdala and ventro-lateral prefrontal cortex. The OFC is associated with inhibitory control, risk-taking behavior, and reward learning which are major components of bipolar mania. Thus, the association between OFC with mania symptoms, inhibitory control, risk-taking behavior, and reward processing suggests that this region could be targeted using non-invasive brain stimulation.

Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19 - Completed

COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue), neurological complications and and mainly disorders of the respiratory system, such as respiratory muscle weakness after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation (tDCS) have been proposed to minimize functional and structural impairments. The aim of the present study is to evaluate the effects of inspiratory muscle training associated with stimulation of the diaphragmatic motor cortex through hd-tdcs in post-COVID-19 patients on inspiratory muscle strength, pulmonary function, inflammatory levels and functional capacity.

More on COVID-19 (Coronavirus Disease 2019)

Sponsor
Federal University of Paraíba

Complete information at Clinical Trials.Gov

The Soterix Medical 1x1 mini-CT and 4X1 devices are being used in the study. The mini-CT provides unmatched controlled and reliability in conducting tDCS or tES trials in deployed environments without compromising dose precision and safety. The Soterix 4×1 HD-tDCS adaptor converts any 2-channel tDCS stimulator into an HD-tDCS device. The 4×1 HD-tDCS adaptor is not a stand-alone stimulator, and during stimulation does not generate any current. Rather, the 4×1 HD-tDCS adaptor intelligently divides and guides current generated by a 2-channel device, converting it to HD-tDCS. The Soterix 4×1 HD-tDCS adaptor is thus an ideal solution where an existing 2-channel device is already in use. - mini-CT , HD-tDCS.

Selected References

Feasibility of remote transcranial direct current stimulation for pediatric cerebral palsy during the COVID-19 pandemic. Lench DH, Simpson E, Sutter EN, Gillick BT. Brain Stimul. 2020 Nov - Dec;13(6):1803-1804. doi: 10.1016/j.brs.2020.10.010. Epub 2020 Oct 23.
Guidelines for TMS/tES clinical services and research through the COVID-19 pandemic. Bikson, M., Hanlon, C. A., Woods, A. J., Gillick, B. T., Charvet, L., Lamm, C., Madeo, G., Holczer, A., Almeida, J., Antal, A., Ay, M. R., Baeken, C., Blumberger, D. M., Campanella, S., Camprodon, J. A., Christiansen, L., Loo, C., Crinion, J. T., Fitzgerald, P., Gallimberti, L., … Ekhtiari, H. Brain stimulation 2020.
Transcranial direct current stimulation as a strategy to manage COVID-19 pain and fatigue. Silva Filho E, Moura S, Santos ADC, Brasileiro-Santos MDS, Albuquerque JA. Rev Assoc Med Bras (1992). 2021.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Non-invasive Brain Stimulation of the Prefrontal Cortex in Substance Use Disorders - Recruiting

In this study, we aim to investigate the effect of HD-tDCS, a more focal stimulation variant, on subjects with Alcohol Use Disorder (AUD). Using this intervention, stimulation can be restricted to one hemisphere, controlling for possible inhibition effects of the cathode. A between-subject design will be carried out, including patients with an AUD. Participants will receive 5 sessions of either real or sham right anodal HD-tDCS over the dorsolateral prefrontal cortex (dlPFC). Craving will be accounted for at baseline and after every stimulation session. Moreover, we will measure the activity of the brain in rest and during two inhibition tasks (Go/NoGo and cue reactivity task). This objective measure will be carried out both before (baseline) and at two time points after the stimulation, to measure effects on both the short and longer term. One month after the intervention, abstinence will be checked through a follow-up phone call. Through this study, we aim to describe positive effects of right dlPFC stimulation on craving, abstinence, and EEG measures.

Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response - Recruiting

The investigators have designed a pragmatic trial of home-based transcranial direct current stimulation (tDCS) for phantom limb pain (PLP), the PLP-EVEREST trial (PLP-EffectiVEness pRagmatic Stimulation Trial) to test a portable device that would reach underrepresented populations and would validate this therapy in a more pragmatic setting. Subjects will be randomized to home-based tDCS of the primary motor cortex (M1) with somatosensory training or usual care only (including their current pharmacological treatments, physical therapy, and occupational therapy). The investigators will therefore test the effectiveness of home-based tDCS and somatosensory training in a real-world, home-based setting. The Investigator will compare patients randomized to this combined strategy vs. usual care alone (subjects from this group will be offered combined treatment at the end of the trial). The investigators hypothesize that the combined strategy will be associated with a significantly larger Cohen's d effect size (at least 1) compared to the control group.

SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults - Completed

The current study will investigate methods for enhancing cognitive training (CT) effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. A pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). A precision dosing algorithm will be used to determine the appropriate levels of current and location of electrodes to deliver current using tDCS.

Sponsor
University of Florida

Collaborator
Soterix Medical

Complete information at Clinical Trials.Gov

Selected References

Comparison between conventional and HD-tDCS of the right inferior frontal gyrus in children and adolescents with ADHD. Breitling C, Zaehle T, Dannhauer M, Tegelbeckers J, Flechtner HH, Krauel K. Clin Neurophysiol. 2020.
Working memory training with tDCS improves behavioral and neurophysiological symptoms in pilot group with post-traumatic stress disorder (PTSD) and with poor working memory. Saunders N, Downham R, Turman B, Kropotov J, Clark R, Yumash R, Szatmary A. Neurocase 2015.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Effect of Noninvasive Electrical Brain Stimulation on Memory at Different Times of Day in Younger and Older Adults - Completed

This study will investigate the extent to which tDCS to dorsolateral prefrontal cortex (or dlPFC) impacts memory performance as a function of time-of-day in younger and older adults.

Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study - Completed

This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes.

More on Aphasia

Modulating Prospective Memory in Older Adults With Non-invasive Brain Stimulation - Completed

This study aims to modulate neural activity in the left and right inferior frontal lobe as well as in the right superior parietal lobe via high-definition transcranial direct current stimulation (HD-tDCS) in older adults. There is evidence from functional magnetic resonance imaging (fMRI) studies that these areas are involved in prospective memory performance in younger and older adults but a causal relation between activity in these areas and responses in prospective memory tasks has not been established so far. It is hypothesized that stimulation will lead to changes in prospective memory functioning. Further, the investigators expect that facilitation of attentional processes might be linked to prospective memory improvements.

Study of the Synergistic Effects of Biofeedback and Transcranial Electrical Stimulation in Anxio-depressive Disorders - Completed

The first objective of this study is to show that heart rate variability (HRV) biofeedback training coupled with tDCS is associated with a greater decrease in anxious symptomatology. The secondary objective of the study is to show that a coupling of these two techniques is associated with an increase of the variability of the cardiac rhythm as well as a more important decrease of the depressive symptomatology.

More on Depression

Open Label Extension Study of tDCS Plus Guided Imagery for Women With Chronic Pelvic Pain (CPP) - Withdrawn

This is an open label extension study trial of tDCS with a standardized guided imagery intervention. Up to 20 women with chronic pelvic pain, who completed participation in the initial randomized trial (IRB 2019-362) will be enrolled. Subjects will complete 5 tDCS treatments with guided imagery and a 1-week follow-up visit.

Study of the Acute Effects of Guided Imagery and tDCS on Pain Levels in Women With Chronic Pelvic Pain - Withdrawn

This is a single blind, randomized, exploratory study of transcranial direct stimulation (tDCS) intervention or sham tDCS administered with a standardized guided imagery intervention for chronic pelvic pain. Transcranial Direct Current Sstimulation (tDCS) is a non-invasive brain stimulation therapy. Guided Imagery is a form of hypnosis used to create relaxation.Up to 25 adult women with chronic pelvic pain will be enrolled and randomized (like a flip of a coin). Subjects will remain blinded throughout the study. Subjects will be randomized into one of the following four arms: active tDCS with guided imagery, active tDCS alone (without guided imagery), sham tDCS with guided imagery, or sham tDCS alone (without guided imagery).

Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients - Completed

This study aims to evaluate the safety and feasibility of transcranial direct current stimulation (tDCS) in combination with home-based auditory training therapy in cochlear implant (CI) patients. Changes in speech perception performance will also be evaluated.

Maintenance of Response After rTMS for Depression Using tDCS - Completed

This is a double-blind, multi-site, randomized controlled trial (RCT) that will recruit 200 participants.The purpose of the RCT will be to evaluate the efficacy of transcranial direct current stimulation (tDCS) in combination with mindfulness meditation compared to sham tDCS to maintain wellness following an acute course of repetitive transcranial magnetic stimulation (rTMS) for up to 6 months.

More on Depression

Sponsor
Centre for Addiction and Mental Health

Collaborator
University Health Network, Toronto

Access complete clinical trial information here

Selected References

Efficacy and neurophysiological predictors of treatment response of adjunct bifrontal transcranial direct current stimulation (tDCS) in treating unipolar and bipolar depression. Lin, Y. Y., Chang, C. C., Huang, C. C., Tzeng, N. S., Kao, Y. C., & Chang, H. A. Journal of affective disorders, 280(Pt A), 295–304. 2021 Feb 1.
Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study. Goerigk S, Cretaz E, Sampaio-Junior B, Vieira ÉLM, Gattaz W, Klein I, Lafer B, Teixeira AL, Carvalho AF, Lotufo PA, Benseñor IM, Bühner M, Padberg F, Brunoni AR. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Oct 4.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Remotely Supervised tDCS for Slowing ALS Disease Progression - Active, not recruiting

Most ALS care is centered on patient support and symptom management, making rehabilitation an integral aspect for slowing disease progression, prolonging life span, and increasing quality of life. Brain stimulation has been increasingly explored as a promising neuromodulatory tool to prime motor function in several neurological disorders. We propose a novel mechanism using remotely supervised brain stimulation to preserve motor function in individuals with ALS. This project will also aim to explore the effectiveness of brain stimulation on upper and lower motor neuron mechanisms in individuals with ALS.

More on Amyotrophic Lateral Sclerosis (ALS)

Sponsor
University of Illinois at Chicago

Collaborator
University of Chicago

Access complete clinical trial information here

Selected References

Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice. Charvet LE, Shaw MT, Bikson M, Woods AJ, Knotkova H. Brain Stimul. 2020 May-Jun;13(3):686-693.
Walking in multiple sclerosis improves with tDCS: a randomized, double-blind, sham-controlled study. Pilloni, G., Choi, C., Shaw, M. T., Coghe, G., Krupp, L., Moffat, M., Cocco, E., Pau, M., & Charvet, L. Annals of clinical and translational neurology, 7(11), 2310–2319. 2020 Nov.
Neuroimaging Indicates Response to Transcranial Direct Current Stimulation Treatments in Multiple Sclerosis (1892). Lillian Walton Masters, Marco Muccio, Peidong He, Claire Choi, Abhishek Datta, Marom Bikson, Lauren Krupp, Yulin Ge, Leigh Charvet Neurology Apr 2020, 94 (15 Supplement) 1892.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Neurostimulation for Cognitive Enhancement in Alzheimer's Disease - Recruiting

The prevalence of Alzheimer's Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. This randomized sham-controlled trial will determine if an innovative low-risk remotely-supervised transcranial Direct Current Stimulation (tDCS) applied over the area of the dorsolateral prefrontal cortex for 30 minutes at the intensity of 2 mA five times per week for 6 months at home can improve cognitive performance and symptoms and modulate neuroimaging markers of neuroplasticity in 100 patients with mild to moderate AD. If effective, this novel intervention can substantially enhance AD symptom management at home, improve quality of life of AD patients and their families, and reduce burden associated with this debilitating illness.

Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction - Completed

Quadriceps muscle dysfunction persists for years after anterior cruciate ligament reconstruction (ACLR) and is related to poor self-reported outcomes, altered movement patterns and joint loading associated with post-traumatic knee osteoarthritis (OA), and higher risk of reinjury. Emerging evidence indicates that central drive (pathway from the brain to the muscle of interest, i.e corticospinal excitability) to the quadriceps muscle is reduced as early as 2 weeks after surgery and can persist for years after ACLR, meaning that current rehabilitation strategies may not be addressing potential maladaptive changes in central drive. Anodal tDCS is a neurostimulation technology that increases brain excitability (i.e. central drive) and has the potential to address alterations in central drive and quadriceps muscle performance. The purpose of this study is twofold: 1) to determine the effects of anodal tDCS on central drive and quadriceps muscle performance in patients after ACLR, and 2) determine the relationship between central drive and quadriceps muscle performance in patients after ACLR.

More on Anterior Cruciate Ligament Reconstruction

HDtDCS in Logopenic Variant PPA: Effects on Language and Neural Mechanisms - Completed

This study aims to evaluate the effectiveness of a therapy called High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for the treatment of the language deficits experienced by people with a type of Primary Progressive Aphasia. This study uses a combination of brain imaging, language assessment, language training sessions, and HD-tDCS therapy as well as placebo therapy sessions.

More on Aphasia

Sponsor
Medical College of Wisconsin

Access complete clinical trial information here

The Soterix Medical MXN device is being used in the study. The MXN is part of the exclusive High-Definition platform which provides researchers with unprecedented targeted stimulation of neuronal structures.

Selected References

Multiple high dose tDCS sessions produces perceived improvement and stabilisation in a person with a MAPT gene, presenting clinically as semantic variant primary progressive aphasia with severe cognitive impairment. Roncero, C., Popov, A., & Chertkow, H. Brain stimulation, 14(2), 358–360. 2021 Feb 6.
White Matter Integrity Predicts Electrical Stimulation (tDCS) and Language Therapy Effects in Primary Progressive Aphasia. Zhao, Y., Ficek, B., Webster, K., Frangakis, C., Caffo, B., Hillis, A. E., Faria, A., & Tsapkini, K. Neurorehabilitation and neural repair, 35(1), 44–57. 2021 Jan.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Pilot Study of Transcranial Direct Current Stimulation (tDCS) - Completed

This study will test the tolerability and preliminary efficacy of transcranial direct current stimulation (tDCS) combined with a cognitive training program, remotely-delivered using a telemedicine protocol in 60 adults with multiple sclerosis (MS). The study will evaluate the efficacy of tDCS to evaluate two of the most debilitating symptoms of MS: cognitive impairment and fatigue.

Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment - Completed

This prospective interventional single center randomized sham controlled dose-escalation study will assess safety, tolerability, feasibility and potential efficacy of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion who are ineligible for both intravenous thrombolysis (IV tPA) and endovascular therapy (EVT). Patients will be randomized in a 3:1 design, to cathodal versus sham (control) tDCS, at each six designed dose tiers. The dose tiers will be increasing in both intensity and duration of the stimulation. The occurrence of symptomatic intracranial hemorrhage will determine the pace of the escalation through the dose tiers.

More on Stroke

Sponsor
General University Hospital, Prague

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Selected References

Transcranial pulse current stimulation improves the locomotor function in a rat model of stroke. Wang, W. J., Zhong, Y. B., Zhao, J. J., Ren, M., Zhang, S. C., Xu, M. S., Xu, S. T., Zhang, Y. J., & Shan, C. L. Neural regeneration research, 16(7), 1229–1234. 2021 Jul.
Backward locomotor treadmill training combined with transcutaneous spinal direct current stimulation in stroke: a randomized pilot feasibility and safety study. Awosika OO, Matthews S, Staggs EJ, Boyne P, Song X, Rizik BA, Sucharew HJ, Zhang C, Mungcal G, Moudgal R, Bhattacharya A, Dunning K, Woo D, Kissela BM. Brain Commun. 2020 Apr 21;2(1):fcaa045.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

HD-tDCs to Improve Upper Extremity Function in Patients With Acute Middle Cerebral Artery Stroke - Withdrawn

The purpose of this study is to determine if using targeted high definition transcranial direct current stimulation can improve upper extremity motor function in patients with subacute middle cerebral artery (MCA) stroke. Current research suggests there may be potential benefit using high definition transcranial direct current stimulation in patients with upper extremity hemiparesis secondary to an ischemic stroke. The intervention has effects on the damaged neurons within the person's brain after stroke, possibly amplifying the body's own healing process. Lesions within the brain may alter the flow of current through that area. The software system, HD-Targets, will be used that takes the patient's own MRI to account for variabilities in skull thickness, lesion size/location/composition, fluid density, and cerebrospinal fluid presence. These variabilities are used in the computer algorithm that simulates current flow through that specific participant's brain to get to the desired target area with the least amount of current and decreased stimulation of undesired areas. The investigators will examine these patients before and after treatment and compare the two groups, treatment group and sham group, after they receive 10 sessions of 20 minutes along with their regular course of physical, occupational, or speech therapy over the course of their inpatient rehab stay.

Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure - Completed

Gulf War Veterans (a DoD/VA defined service era corresponding to the first Gulf War under operations Desert Storm and Desert Shield 1990-1991), especially those who present with Post-Traumatic Stress Disorder (PTSD), are particularly likely to experience chronic pain. Veterans with co-morbid chronic pain and PTSD utilize healthcare services at a higher rate than those with pain or PTSD alone. Unfortunately, there are no integrated treatments for Pain and PTSD. Moreover, non-pharmacological treatments for pain such as Cognitive Behavioral Therapy are useful in only about 50% of cases. Transcranial direct current stimulation (tDCS) may be an effective treatment for pain, and has been recently used to ameliorate PTSD symptoms. Prolonged Exposure Therapy (PE) is highly effective in treating PTSD symptoms. Therefore, we propose to (a) integrate & (b) gather feasibility data for home-based tDCS + PE for Pain and PTSD with 15 Gulf War Veterans. The Overall Aim of the present proposal is to integrate, refine and investigate the feasibility (e.g., pilot testing, recruitment, attrition, assessment) of tDCS for treating chronic pain with a best practices evidence-based treatment for PTSD (i.e., Prolonged Exposure: PE) in 15 Gulf War veterans, a group for which both pain (fibromyalgia) and PTSD are particularly problematic.

tDCS and Aphasia Treatment - Completed

This project will investigate the use of noninvasive brain stimulation in the form of tDCS (transcranial direct current stimulation) in conjunction with speech-language therapy, for the improvement of language production in stroke survivors with aphasia. The hypothesis is that anodal tDCS and speech-language therapy will facilitate improved outcomes compared to speech therapy alone.

More on Aphasia

Sponsor
Hunter College of City University of New York

Access complete clinical trial information here

Selected References

Multiple high dose tDCS sessions produces perceived improvement and stabilisation in a person with a MAPT gene, presenting clinically as semantic variant primary progressive aphasia with severe cognitive impairment. Roncero, C., Popov, A., & Chertkow, H. Brain stimulation, 14(2), 358–360. 2021 Feb 6.
White Matter Integrity Predicts Electrical Stimulation (tDCS) and Language Therapy Effects in Primary Progressive Aphasia. Zhao, Y., Ficek, B., Webster, K., Frangakis, C., Caffo, B., Hillis, A. E., Faria, A., & Tsapkini, K. Neurorehabilitation and neural repair, 35(1), 44–57. 2021 Jan.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Home-administered tDCS for Treatment of Depression - Completed

This study will determine the safety and efficacy of home administered tDCS in adults with unipolar depression. The device used to administer tDCS will be the Soterix Medical 1X1 mini-CT. 32 tDCS sessions of 30 minutes each will be delivered over 10 weeks. The Soterix Medical 1X1 mini-CT will be used to determine the safety and efficacy of home-based transcranial direct current stimulation (tDCS) in treating unipolar depression. Specifically efficacy will be determined by change in MADRS score from baseline to the 10 week follow-up. Feasibility and compliance will be determined by low drop out rate and percentage of scheduled sessions completed.

More on Depression

Sponsor
Soterix Medical

Collaborator
NYU Langone Health

Access complete clinical trial information here

Selected References

Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice. Charvet LE, Shaw MT, Bikson M, Woods AJ, Knotkova H. Brain Stimul. 2020 May-Jun;13(3):686-693.
Efficacy and neurophysiological predictors of treatment response of adjunct bifrontal transcranial direct current stimulation (tDCS) in treating unipolar and bipolar depression. Lin, Y. Y., Chang, C. C., Huang, C. C., Tzeng, N. S., Kao, Y. C., & Chang, H. A. Journal of affective disorders, 280(Pt A), 295–304. 2021 Feb 1.
Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study. Goerigk S, Cretaz E, Sampaio-Junior B, Vieira ÉLM, Gattaz W, Klein I, Lafer B, Teixeira AL, Carvalho AF, Lotufo PA, Benseñor IM, Bühner M, Padberg F, Brunoni AR. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Oct 4.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis - Completed

The purpose of the research is to test out a new form of treatment that examines stimulation of a nerve in the participant's ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive stimulation through the ear. The taVNS device looks like an ear bud used with a smartphone or computer. The study team is investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.

Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial - Completed

The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)

Home-Administered Trial of Direct Current Stimulation (HAT-DCS) - Completed

Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. This study will evaluate the feasibility and efficacy of home-administered tDCS treatment for depression.

More on Depression

More on Soterix Medical Remote tDCS Platforms

Sponsor
The University of New South Wales

Access complete clinical trial information here

Selected References

Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice. Charvet LE, Shaw MT, Bikson M, Woods AJ, Knotkova H. Brain Stimul. 2020 May-Jun;13(3):686-693.
Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Charvet L, Shaw M, Dobbs B, Frontario A, Sherman K, Bikson M, Datta A, Krupp L, Zeinapour E, Kasschau M. Neuromodulation. 2018 Jun;21(4):383-389. doi: 10.1111/ner.12583

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotion After Spinal Cord Injury - Completed

This study will investigate the effects of transcutaneous direct current stimulation (tsDCS) on walking function in individuals with incomplete spinal cord injury. Following rehabilitation, individuals with ISCI often demonstrate improved walking function, but continue to have serious impairments that limit mobility, community participation, and quality of life. Adjuvants to rehabilitation that increase spinal excitation during training may enhance its effectiveness. tsDCS is a non-invasive neuromodulation approach that uses a mild electrical current, applied over the skin of the lower back, to alter the membrane potential of spinal neurons.

tsDCS will be applied during locomotor training, a well-established rehabilitation strategy that promotes walking recovery. The study team will explore if tsDCS combined with locomotor training increases spinal excitation and thereby improves the effectiveness of walking rehabilitation.

More on Spinal Cord Injury (SCI) from MedlinePlus.

Sponsor
University of Florida

Collaborator
National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation for the Management of Multiple Sclerosis Related Fatigue - Completed

This is a pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS participants to reduce feelings of fatigue.120 participants with MS and clinically-significant fatigue (as defined by a score of >36 on the Fatigue Severity Scale) will be recruited to participate in either an active or sham treatment condition.

Access complete clinical trial information here.

More information on Multiple Sclerosis (MS) from the National Institute of Health.

Sponsor
NYU Langone Health

Collaborator
National Multiple Sclerosis Society

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Impact of Neuromodulation on Language Impairments in Stroke Patients: a Multimodal Double-blind Randomized Controlled Study - Completed

Approximately one million people in the United States are living with aphasia, an acquired neurologic disorder affecting the ability to use and/or understand language. This communication impairment affects up to 40% of stroke patients. Stroke victims usually prioritize speaking, writing, and walking as the three most important rehabilitation goals, two of these goals therefore involving communication. Conventional speech therapy strategies have nevertheless limited effectiveness in post-stroke aphasia. Effective novel treatment is therefore warranted to improve recovery in these patients. A double-blind randomized controlled design will be conducted. Participants will randomly be assigned either to the tDCS group or to the sham (placebo) group. The only person knowing about this assignment will be the research coordinator. Both groups will include five consecutive days of 20 minutes sessions.

The Soterix Medical transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system is being used in the study. The Soterix Medical 1x1- CT the most advanced and customizable stimulation for true double-blind control trials. Each 1x1-CT unit is configured to a specific trial or set of trials, to ensure the highest standards of reproducibility and safety, all without breaking subject’s or operator’s blind. More on Soterix Medical transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system.

Access complete clinical trial information here.

More information on Aphasia from the Mayo Clinic.

Sponsor
Casa Colina Hospital and Centers for Healthcare

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation in Major Depression - Completed

The first part of the trial will compare how current flow and functional imaging signal differs in the brain when using tDCS with more focal stimulation, called high definition (HD) tDCS, compared to conventional tDCS (C-tDCS) or sham (non-active) tDCS in patients with MDD.Sixty people with depression (20 in each group) will be randomized to receive either HD-tDCS, C-tDCS or sham-tDCS for a total of 12 sessions each lasting 20 minutes occurring on consecutive weekdays. At the first and last session, subjects will receive 20-30 minutes of active or sham tDCS in the MRI scanner.

A custom design of the Soterix Medical MxN line of stimulators is being used in the study. The MxN is the most advanced non-invasive neuromodulation platform ever developed. The M×N delivers High-Definition transcranial Electrical Stimulation, a transformative technology for targeting cortical and deep brain structures with weak currents. The MXN line of stimulators offer non-invasive and targeted stimulation that leverages therapeutic potential, convenience and safety. More on Soterix Medical MxN line of stimulators

Access complete clinical trial information here.

More information on Major Depressive Disorder (MDD) from the National Institute of Mental Health.

Sponsor
University of California, Los Angeles

Collaborator
National Institute of Mental Health (NIMH)

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation for the Treatment of Delirium - Completed

Delirium is induced by changes in cortical excitability and transcranial direct current stimulation (tDCS), by using weak electrical fields, can modulate cortical excitability and spontaneous firing activities in the stimulated region by shifting the resting membrane. One half of the subjects will receive stimulation via tDCS and the other half will receive sham tDCS for 20 minutes per day, 5 days per week, for 1 week. Symptoms will be monitored using the Confusion Assessment Method.

Sponsor
North Florida/South Georgia Veterans Health System

Complete clinical trial information here.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain - Terminated

This is a single blind, randomized controlled pilot trial of transcranial direct stimulation (tDCS) intervention or tDCS sham administered with a standardized guided imagery intervention. Up to 25 adult women with chronic pelvic pain will be enrolled and randomized (like a flip of the coin) to achieve a total sample size of 20 women. 10 women in one arm of the study will receive guided imagery with tDCS stimulation. 10 women in the other arm of the study will receive guided imagery with sham tDCS. Subjects will remain blinded until the end of the study. It is hypothesized that the combination of tDCS and Guided Imagery (GI) will enhance patient outcomes, as evidenced by differences in alpha brain wave changes, pain and quality of life (QOL) measures between tDCS actual and sham treatment groups.

The Soterix Medical 1×1 tDCS device is being used in the study. The Soterix Medical line of tDCS devices are the industry standard for transcranial direct current stimulation, and are the only devices designed especially for tDCS. More on Soterix 1x1 tDCS Devices.

Access complete clinical trial information here.

More information on Chronic Pelvic Pain from the Mayo Clinic.

Sponsor
Kenneth M Peters, MD

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Augmenting Cognitive Training in Older Adults (ACT) - Completed

A two-phase adaptive randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and could enhance neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and ET combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state. Functional magnetic resonance imaging (FMRI) will be used to assess brain response during working memory, attention, and memory encoding; the active cognitive abilities trained by CT. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including GABA concentrations sensitive to neural plasticity.

Complete information at Clinical Trials.Gov

Sponsor
University of Florida

Collaborator
University of Arizona
National Institute on Aging (NIA)

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study - Completed

The purpose of this study is to investigate whether giving transcranial direct current stimulation (tDCS) treatment using an investigational device called the Soterix tES Device (tDCS device) on the right side of the brain can improve performance on cognitive tests. Investigational means that the tDCS device is not approved by the U.S. Food and Drug Administration (FDA) for the use in this study.

tDCS is a non-invasive way to electrically stimulate the brain. The tDCS device is portable and runs on two 9-volt batteries. Electrodes from the tDCS device carry weak electrical current through the scalp and skull and into the brain. When the direction of the electric current flow is called cathodal, the brain under the site of stimulation reduces its activity.

When tasks are performed, certain parts of the brain are activated. Research studies have shown that younger adults and older adults activate similar parts of the brain when performing the same task (a memory task, for example). However, other researchers found older adults who scored worse on memory tasks, and those with Mild Cognitive Impairment, activated an additional part of the brain so both sides of the brain are activated. Researchers are not sure whether this additional activation is helpful or not. Investigators in this study believe that this extra activation may be contributing to worse performance on tasks.

It may be possible to use tDCS to reduce the brain activity on the extra activation (right) side in older adults, to resemble an activation pattern seen in younger adults (or higher scoring cohort). Using cathodal tDCS to reduce brain activity might help the brain in performing tasks.

More on MCI at: https://www.nia.nih.gov/health/what-mild-cognitive-impairment

Sponsor
Mayo Clinic

Complete information at Clinical Trials.Gov

For more information: tES

Selected References

Cognitive Training and Transcranial Direct Current Stimulation for Mild Cognitive Impairment in Parkinson's Disease: A Randomized Controlled Trial. Lawrence BJ, Gasson N, Johnson AR, Booth L, Loftus AM.Parkinsons Dis. 2018 Mar 26;2018:4318475.
The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study. Cruz Gonzalez P, Fong KNK, Brown T. Behav Neurol. 2018 Mar 15;2018:5971385.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees - Completed

This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.

More on phantom limb pain at: https://www.ncbi.nlm.nih.gov/pubmed/29780572

Sponsor
Spaulding Rehabilitation Hospital

Complete information at Clinical Trials.Gov

Selected References

Immediate and Sustained Effects of 5-Day Transcranial Direct Current Stimulation of the Motor Cortex in Phantom Limb Pain. Bolognini N, Spandri V, Ferraro F, Salmaggi A, Molinari AC, Fregni F, Maravita A. J Pain. 2015 Jul;16(7):657-65.
Long-term analgesic effects of transcranial direct current stimulation of the motor cortex onphantom limb and stump pain: a case report. Bolognini N, Spandri V, Olgiati E, Fregni F, Ferraro F, Maravita A. J Pain Symptom Manage. 2013 Oct;46(4):e1-4.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Depression - Withdrawn

The proposed study seeks to obtain preliminary signal of the tolerability and efficacy of transcranial direct current stimulation (tDCS) for depressive symptoms in a sample of adolescents with depression and epilepsy. Additionally, effects of tDCS will be assessed via electroencephalographic, cognitive, and psychosocial measures.

More on Epilepsy at: https://medlineplus.gov/epilepsy.html

More on Depression at: https://www.nimh.nih.gov/health/topics/depression/index.shtml

Sponsor
Mayo Clinic

Complete information at Clinical Trials.Gov

Selected References

Transcranial Direct Current Stimulation: Considerations for Research in Adolescent Depression. Lee JC, Lewis CP, Daskalakis ZJ, Croarkin PE. Front Psychiatry. 2017 Jun 7;8:91. doi: 10.3389/fpsyt.2017.00091. eCollection 2017. Review.
Transcranial Magnetic and Direct Current Stimulation in Children. Hameed MQ, Dhamne SC, Gersner R, Kaye HL, Oberman LM, Pascual-Leone A, Rotenberg A. Curr Neurol Neurosci Rep. 2017 Feb;17(2):11. doi: 10.1007/s11910-017-0719-0. Review.
Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. Muszkat D, Polanczyk GV, Dias TG, Brunoni AR. Psychopharmacol. 2016 Sep;26(7):590-7. doi: 10.1089/cap.2015.0172. Epub 2016 Mar 30. Review.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

MARt-Depression Trial - Completed

This is an open label pilot feasibility study that will recruit 15 participants. The purpose of the pilot study will be to evaluate the feasibility of open label Transcranial direct current stimulation (tDCS) in combination with computerized cognitive behavior therapy (cCBT) to maintain wellness following an acute course of Electroconvulsive therapy (ECT) for up to 6 months.

More on Depression at: https://www.nimh.nih.gov/health/topics/depression/index.shtml

Sponsor
Centre for Addiction and Mental Health

Complete information at Clinical Trials.Gov

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation (tDCS- Aphasia) –Completed

Aphasia is a symptom of brain damage and affects approximately one million Americans. The purpose of this study is to assess the changes in language processing of patients with chronic aphasia after receiving non-invasive brain stimulation.Previous research using traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has shown that persons with aphasia show more improvement after treatment when that treatment is accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver current to more specific locations in the brain. This new delivery method is called high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse current delivery) or HD-tDCS (more focal current delivery) will be the better approach for enhancing treatment outcomes. To answer this question, computerized speech-language treatment will be administered during the application of the different forms of brain stimulation.

Soterix Medical MxN devices are being used in the study. The MxN is part of the exclusive High-Definition platform which provides researchers with unprecedented targeted stimulation of neuronal structures For more information on Soterix M×N HD-tDCS
The MxN device is used in combination with HDTargets and HDExplore to determine stimulation electrode locations and individual injection currents. For more information on Soterix Software

More on aphasia from National Institue of Health

Sponsor
Soterix Medical

Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Complete information at Clinical Trials.Gov

Selected References

Press Release
Soterix Medical announces completion of Stroke- Aphasia Trial.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment – Completed

The aging US population threatens to overwhelm our healthcare infrastructure, especially since the rate of Alzheimer's disease (AD) alone is expected to triple in the coming decades. Memory cause functional impairment, reduced quality of life, increased caregiver burnout, and eventual institutionalization. The diagnosis of mild cognitive impairment (MCI) identifies those with memory deficits but who remain relatively independent in everyday life. MCI provides a window for interventions that target memory functioning. The proposed study focuses specifically on a groundbreaking combination of mnemonic rehabilitation and non-invasive brain stimulation. The main idea is that brain stimulation can enhance functioning in the specific brain regions/networks, thereby increasing the patients' ability to benefit from different types of memory rehabilitation. This will be a randomized, double-blind study (active vs. fake brain stimulation), that provides multiple treatment session. Outcome will be examined using both laboratory-based and real-world memory testing as well as brain imaging. This first-of-its-kind study has the potential to meaningfully translate more "basic" science findings into neuroanatomically targeted and functionally meaningful treatments for our aging population.

More on Mild Cognitive Impairment at: https://www.nlm.nih.gov/medlineplus/mildcognitiveimpairment.html

Sponsor
VA Office of Research and Development

Collaborators:
VA Office of Research and Development

Complete information at Clinical Trials.Gov

Soterix Medical 1x1 devices are being used in the study. The 1x1 is the clinical industry standard for safe and precise tDCS (https://soterixmedical.com/research/1x1/Overview)

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis (tDCS) – Completed

This study is testing whether the addition of a noninvasive form of brain stimulation called transcranial direct current stimulation (tDCS) when combined with meditation helps decrease the abdominal pain in patients with chronic pancreatitis. Learn more about Soterix tDCS Devices

Access more information on fibromylgia here
Complete clinical trial information here

Sponsor
Beth Israel Deaconess Medical Center

Collaborator
Spaulding Rehabilitation Hospital

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Effects of Transcranial Direct Current Stimulation (tDCS) and Motor Learning in Children With Cerebral Palsy (CP) – Completed

In this study, the investigators aim to assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy. Investigators will use different assessment techniques, such as transcranial magnetic stimulation (TMS) and kinematics (sensors) to measure changes through the trial.

Access more information on cerebral palsy here
Complete clinical trial information here

Sponsor
Spaulding Rehabilitation Center

Collaborator
Pedal with Pete

Soterix Medical 1x1 tDCS device being used in the study. Soterix Medical 1x1 tDCS device is the only tDCS device designed with feedback from the clinicians at leading clinical centers. Learn more about 1×1 tDCS

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury – Completed

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow-up visits at 2, 4 and 8 weeks after initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation. If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

Soterix Medical 1x1 Clinical Trial (CT) devices are being used in the study. The 1x1 CT is the only tDCS Device allowing true double-blinding and full customization specific to each trial. Learn more on Soterix 1×1 CT Device
Access complete clinical trials information here

Sponsor
Spaulding Rehabilitation Hospital

Collaborator
U.S. Department of Education

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury – Completed

Every year, more than 10,000 people in the U.S. sustain a spinal cord injury (SCI). An SCI changes a person’s life in an instant, creating new challenges for everyday life. The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with spinal cord injury. This study is part of the Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation. If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

Soterix Medical 1x1 devices are being used in the study. The 1x1™ is the clinical industry standard for safe and precise tDCS. Learn More on Soterix 1×1™
Access complete clinical trials information here

More on spinal cord injury from the National Spinal Cord Injury Association

Sponsor
Spaulding Rehabilitation Hospital

Collaborator
U.S. Department of Education

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia - Completed

A common and potentially debilitating late effect of childhood cancer treatment is neurocognitive impairment, frequently in the domain of executive dysfunction, which can limit educational attainment, employment, and quality of life. Among the survivors of childhood acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of executive function impairment has been shown as high as 58.8%, with moderate to severe impairment as high as 33.5%, and risk for impairment increased with time from diagnosis. Given the potential of pervasive impact of neurocognitive impairment on daily life, interventions directed at reducing neurocognitive dysfunction among childhood cancer survivors with long-term follow-up are needed. This study examines the potential feasibility and efficacy of a novel intervention to improve executive function.

More on Acute Lymphoblastic Leukemia at: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0024328/

Sponsor
St. Jude Children's Research Hospital

Complete information at Clinical Trials.Gov

Soterix Medical 1x1 mini- Clinical Trial (mini-CT) devices are being used in the study. The 1x1 mini-CT is the only tDCS Device allowing true double-blinding and full customization specific to each trial. For more information - mini-CT

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Analgesic Effect of Cathodal tDCS Over Right DLPFC in Subjects With Muscular TMD: a Double Blind Crossover RCT- Completed

HYPOTHESIS: The investigators believe that neuromodulation by tDCS over DLPFC would decrease the anxiety level and consequently the muscular hyperactivity that is an important etiological factor of TMD. For that, the masseter motor evoked potential (MEP) will be used to verify any change.
AIM: To investigate if cathodal tDCS over right DLPFC has analgesic effects in subjects with muscular TMD.

More on Muscular TMD at: http://www.nidcr.nih.gov/oralhealth/Topics/TMJ/TMJDisorders.htm

Sponsor
Federal University of Bahia

Complete information at Clinical Trials.Gov

Soterix Medical 1x1 devices are being used in the study. The 1x1 is the clinical industry standard for safe and precise tDCS (https://soterixmedical.com/research/1x1/Overview)

Selected References

Transcranial direct current stimulation and exercises for treatment of chronic temporomandibular disorders: a blind randomised-controlled trial.
Oliveira LB, Lopes TS, Soares C, Maluf R, Goes BT, Sá KN, Baptista AF.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia – Withdrawn

The purpose of this study is to test the efficacy of transcranial direct current stimulation (tDCS) for the treatment of auditory hallucinations in patients currently on risperidone treatment who are experiencing recent onset psychosis.

More on Schizophrenia at: http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml

Sponsor
Northwell Health

Complete information at Clinical Trials.Gov

Soterix Medical 1x1 devices are being used in the study. The 1x1 is the clinical industry standard for safe and precise tDCS.

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial (ELECT-TDCS) – Completed

Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited for issues such as refractoriness and adverse effects. In this context, the investigators investigate a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). To prove that tDCS is similarly effective than antidepressants would have a tremendous impact in clinical psychiatry, since tDCS is virtually absent of adverse effects. Its ease-of-use, portability and low price are also interesting characteristics for using in primary and secondary health care. Thus, our aim is to compare tDCS against a fully dosed, effective antidepressant. The study will be a non-inferiority, randomized, double-blinded, placebo-controlled, three-arm trial comparing active tDCS/placebo pill, sham tDCS/escitalopram 20mg/day and sham tDCS/placebo pill. Our primary aim is to show that tDCS is not inferior to escitalopram 20mg/day with a noninferiority margin of at least 50% of the escitalopram-placebo effect.

More on Depression at: https://www.nimh.nih.gov/health/topics/depression/index.shtml

Sponsor
University of Sao Paulo

Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo

Complete information at Clinical Trials.Gov

Selected References

The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS): rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial.
Brunoni AR., Sampaio-Junior B., Moffa AH., Borrione L., Nogueira BS., Aparício LV., Veronezi B., Moreno M., Fernandes RA., Tavares D., Bueno PV., Seibt O., Bikson M., Fraguas R., Benseñor IM.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain – Completed

In this study the investigators aim to examine the effects of Transcranial Direct Current Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing in individuals with chronic pain of the cornea -- and also compared with healthy controls.

Soterix Medical 1×1 devices are being used in the study. The 1×1 is the indutry standard for safe and precise tDCS. Learn more on Soterix 1×1 Device
Access complete clinical trials information here

More on corneal pain from the Boston Foundation for Sight.

Sponsor
Spaulding Rehabilitation Hospital

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Effects of rTMS and tDCS on Motor Function in Stroke – Completed

Stroke is the fourth leading cause of death in America and a leading cause of adult disability. In this study the investigators aim to investigate the effects of two different types of non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This is a cross-over study where subjects will receive 5 sessions of stimulation (each separated by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham tDCS and rTMS.

More on stroke from the National Stroke Association

Sponsor
Spaulding Rehabilitation Hospital

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation for the Treatment of Bipolar Depression (TDCS-BD) - Completed

Non-invasive brain stimulation therapies have been increasingly investigated in recent years as a treatment for neuropsychiatric disorders, particularly mood disorders. They are particularly appealing since many patients are either refractory or present side effects to standard pharmacological regimens. TDCS (transcranial direct current stimulation). a novel non- pharmacological brain stimulation technique, might help in overcoming some of these issues, since it has low cost, high portability and it is relatively easy to use. TDCS consists in applying a weak, direct current through two electrodes placed over the scalp; the anode and the cathode increasing and decreasing cortical excitability during and beyond the period of stimulation. It is also a safe technique with only mild adverse effects described. Previous studies, some of them from our group, have described that tDCS is an effective technique for major depression. However, the role of tDCS as a treatment for bipolar depression (BD) has been insufficiently investigated. Therefore, our aim is to address the antidepressant effects of tDCS in BD in a randomized, sham- controlled trial in a refractory sample

Access more information on depression here
Complete clinical trial information here

Sponsor
University of Sao Paulo

Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo

From the investigator/sponsor's desk
"The BETTER study will be one of the largest trials to date assessing the efficacy of tDCS specifically in bipolar depression. The sample size was adequately powered to minimize type I and type II errors and to handle a study attrition of up to 15%. We will also enroll patients with type I and type II bipolar depression, of different degree of refractoriness and also enrolling anxiety disorders as a comorbidity, which will enhance external generalizability of tDCS in different contexts…. The BETTER study will address the efficacy of transcranial direct current stimulation for bipolar disorder patients with treatment-resistant depression using a randomized, sham-controlled design. The investigation of the relationship of biological markers with depression response will also contribute in understanding the pathophysiology of bipolar depression as well as the mechanisms of action of this new technique of neuromodulation. Therefore, our trial can generate important findings in the fields of clinical treatment of bipolar depression and noninvasive brain stimulation"

Soterix Medical 1x1-Clinical Trials (CT) device using Limited Total Energy (LTE) technology is being used in the study. The LTE is only tDCS technology optimized for susceptible populations (pediatric, stroke, TBI). The 1x1-CT is only tDCS device optimized for true double-blind trials.
Learn more about Soterix Medical LTE and CT.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Cognitive Stimulation Study (CogStim) - Completed

This study will evaluate the influence of non-invasive brain stimulation on different elements of cognitive function in healthy persons between the ages of 18-90 years. It will specifically use transcranial direct current stimulation (tDCS) to evaluate the relationship between certain brain structures and cognitive abilities, like attention, working memory, visual search, etc.
Hemisphere Stimulation
Participants will receive 1mA vs. 2mA transcranial direct current stimulation of a) right and b) left brain structures (1x1 stimulation), and sham/placebo stimulation. A subset of participants will undergo right and left brain stimulation, but all will undergo sham stimulation.
Temporal Lobe Stimulation
A group of participants will undergo 1x1 transcranial direct current stimulation of the temporal lobes at 1 mA vs. 2 mA vs. sham stimulation. A second group of participants will undergo 1mA or 2mA stimulation, and sham, in right vs. left structures using 4x1 stimulation (e.g., 1mA left temporal, 1mA right temporal, sham; 2mA left temporal, 2mA right temporal, sham).
Frontal Lobe Stimulation
A group of participants will undergo 1x1 transcranial direct current stimulation of the frontal lobes at 1 mA vs. 2 mA vs. sham stimulation. A second group of participants will undergo 1mA or 2mA stimulation, and sham, in right vs. left frontal structures using 4x1 stimulation (e.g., 1mA left frontal, 1mA right frontal, sham; 2mA left frontal, 2mA right frontal, sham).
Parietal Lobe Stimulation
A group of participants will undergo 1x1 transcranial direct current stimulation of the parietal lobes at 1 mA vs. 2 mA vs. sham stimulation. A second group of participants will undergo 1mA or 2mA stimulation, and sham, in right vs. left parietal lobes using 4x1 stimulation (e.g., 1mA left parietal lobes, 1mA right parietal lobes, sham; 2mA parietal lobes, 2mA right parietal lobes, sham).
Supplementary Motor Stimulation
A group of participants will undergo 1x1 transcranial direct current stimulation of the Supplementary Motor Area at 1mA vs. 2mA vs. sham stimulation. A second group of participants will undergo 1mA or 2mA stimulation, and sham, in right vs. left Supplementary Motor Area using 4x1 stimulation (e.g., 1mA left Supplementary Motor Area, 1mA right Supplementary Motor Area, sham; 2mA left Supplementary Motor Area, 2mA right Supplementary Motor Area, sham).
Brain Structure Interactions Group
This cohort will evaluate the interaction between frontal, parietal, temporal, and SMA regions in cognitive function. To accomplish this goal will require evaluation of change in cognitive and neurocognitive performance following transcranial direct current stimulation of different brain regions within the same subjects. For example, we will evaluate the contribution of frontal, SMA, and parietal regions by asking participants to undergo stimulation sessions at each of these sites, in addition to a sham session.

Access more information on cognition here
Complete clinical trial information here

Sponsor
University of Florida

Soterix Medical Soterix 1×1 tDCS device is being used in the study. The Soterix Medical line of tDCS devices are the industry standard for transcranial direct current stimulation, and are the only devices designed especially for tDCS. Learn more on Soterix 1x1 tDCS Devices.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain – Completed

Fibromyalgia affects 6 million Americans and is characterized by chronic widespread pain and allodynia. The purpose of this study is to see the effects of one session of high-definition transcranial direct current stimulation (tDCS) on Fibromyalgia pain. In this patient- and assessor-blind, sham-controlled, crossover trial, 18 patients will be randomized to undergo single 20- minute sessions of anodal, cathodal, and sham HD-tDCS at 2.0 mA in a counterbalanced fashion. Pain scales and sensory testing will be assessed before and after each intervention. The following assessments will be performed at the beginning of every visit: 1) baseline VNS for overall pain; 2) VNS for anxiety; 3) Adapted QOL Scale for persons with chronic illness; 4) BDI-II; 5) Semmes-Weinstein monofilaments (SWMs) for pain and mechanical detection thresholds; 6) pressure pain thresholds (PPTs); and 7) diffuse noxious inhibitory controls (DNICs). Additionally, patients will be asked to keep a pain and medication diary for the duration of the study. On visits 2, 3, and 4, these assessments will be followed by the assigned HD-tDCS sessions. Learn more about Soterix HD-tDCS

Access more information on fibromylgia here
Complete clinical trial information here

Sponsor
Spaulding Rehabilitation Hospital

Collaborator
U.S. Department of Education

Soterix Medical 4x1 device is being used in the study. The 4x1 is part of the exclusive High-Definition platform which provides researchers with unprecedented targeted stimulation of neuronal structures. Learn more on Soterix HD-tDCS

Selected References

Press Release

Soterix Medical Inc. reports positive results from High-Definition tDCS Fibromyalgia Trial at Harvard Medical School

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients - Completed

The purpose of this study is to investigate the mean number of stimulation (high definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS) for pain. These data will be important in defining the optimal number of sessions for future fibromyalgia subjects in Phase III trials. Learn more about Soterix tDCS Devices

Access more information on fibromylgia here
Complete clinical trial information here

Sponsor
Spaulding Rehabilitation Hospital

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

High Definition Cathodal Transcranial Direct Current for Treatment of Focal Status Epilepticus (Phase 1) – Completed

Focal Status epilepticus (FSE) is characterized by a prolonged, self-sustaining, and anatomically discrete seizures that last longer than one hour (at times as long as days or weeks). FSE signs and symptoms can vary according to the function of the brain area engaged but the discharge, and can be as simple as a repetitive limb movement as seen in epilepsy partialis continua (EPC), or as subtle as an inability to write a command or name an object. Prevalence of EPC is estimated to be 1 per one million. The goal of treatment is the rapid termination of the seizure to minimize the acute and chronic effects of this emergency and to allow for the prompt assessment and management of the underlying precipitant. The phases of the trial will be as follows: (1) a baseline 24 h EEG monitoring block that will include a careful seizure diary and peripheral seizure actigraphy sensors to capture the motor and autonomic components of the seizure, (2) 30 minutes of verum or sham cathodal HD-tDCS (3) a follow-up one-day day seizure diary, seizure sensor monitoring and ambulatory 24 h EEG monitoring. No study-related medication changes are expected -- participants will remain compliant with their regular anticonvulsant regimen throughout each study phase, and among inclusion criteria will be absence of medication changes for the 48-hours of each experiment.

Soterix Medical 1X1- Limited Total Energy (LTE) and 4x1 device is being used in the study. The 4x1 is part of the exclusive High-Definition platform which provides researchers with unprecedented targeted stimulation of neuronal structures. Learn more on Soterix HD-tDCS Device. The 1x1-LTE is only tDCS device optimized for suscept population (pediatric, stroke, TBI). For more information on Soterix 1×1 LTE
Access complete clinical trials information here

Sponsor
Children’s Hospital Boston

Collaborator
Epilepsy Foundation

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Robots Paired With tDCS in Stroke Recovery – Completed

Stroke is the fourth leading cause of death in America and a leading cause of adult disability. The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.

Soterix Medical 1x1 Limited Total Energy (LTE) devices are being used in the study. The 1x1-LTE is the only tDCS device optimized for suspectible populations like stroke and pediatric. Learn More on Soterix 1×1 LTE
Access complete clinical trials information here

More on stroke from the National Stroke Association

Sponsor
North Shore Long Island Jewish Health System

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Investigating tDCS as a Treatment for Unipolar and Bipolar Depression - Completed

An estimated 19 million American adults are living with major depression. Almost 2 million Americans currently suffer from bipolar disorder. Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.

Soterix Medical 1x1 Clinical Trial (CT) devices are being used in the study. The 1x1 CT is the only tDCS Device allowing true double-blinding and full customization specific to each trial. More on Soterix 1×1 CT
Access complete clinical trials information here

More on Depression from the National Institue of Mental Health

Sponsor
The University of New South Wales

Collaborator
Duke University
Emory University
Sheppard Pratt Health System
University of Medicine and Dentistry New Jersey
University of Texas

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Randomized, Placebo Controlled Trial of the Efficacy and Tolerability of High Definition Transcranial Direct Current Stimulation to improve IQ in Pediatric Down Syndrome - Completed

In this study investigators will assess safety and tolerability of HD-tDCS administered to 5-8 year old children with Down syndrome. Effects of HD-tDCS to improve IQ, as measured by the Stanford Binet test, will be assessed at multiple time points during the course of the trial. The difference between the scores for IQ after completion of the stimulation sessions and the respective baseline IQ scores will be the measure that will determine efficacy of the intervention.

Soterix Medical 1X1- Limited Total Energy (LTE) and 4x1 device are being used in the study. The 4x1 is part of the exclusive High-Definition platform which provides researchers with unprecedented targeted stimulation of neuronal structures. For more information HD- tDCS. The 1x1-LTE is only tDCS device optimized for suspect population (pediatric, stroke, TBI). For more information on 1×1 LTE

More on Down Syndrome from the National Down Syndrome Society.

Sponsor
University of Wisconsin Madison

Collaborator
U.S. Department of Education

Access complete clinical trials information here.

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (tDCS) - Completed

The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis. The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses: 1) tDCS will not produce a major adverse event, including seizure activity. 2) No change in paretic or nonparetic hand function or cognitive status will occur.

More on Hemiparesis from the National Stroke Association

Sponsor
University of Minnesota - Clinical and Translational Science Institute.

Collaborator
Minnesota Medical Foundation

Access complete clinical trials information here.

Selected References

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

tDCS to Reduce Craving in Cocaine Addiction - Phase 2 Study - Recruiting

The ultimate goal of this project is to develop a portable neuromodulatory intervention to reduce craving in cocaine addiction. This proposed project is in response to NIH/NIDA's solicitation titled "Development of Portable Neuromodulatory Device for the Treatment of Substance Use Disorders (SUDs)." The present study aims to increase the efficacy of repeated administration of tDCS to reduce drug craving in individuals with cocaine addiction.

More on Cocaine Addiction at: National Institute on Drug Abuse

Sponsor
Soterix Medical

Collaborators:
Icahn School of Medicine at Mount Sinai

Complete information at Clinical Trials.Gov
Complete information about phase I at Clinical Trials.Gov

Selected References

A Randomized Placebo-Controlled Trial of Targeted Prefrontal Cortex Modulation with Bilateral tDCS in Patients with Crack-Cocaine Dependence.Batista EK, Klauss J, Fregni F, Nitsche MA, Nakamura-Palacios EM.
Remotely-supervised transcranial direct current stimulation paired with cognitive training in Parkinson's disease: An open-label study.Agarwal S, Pawlak N, Cucca A, Sharma K, Dobbs B, Shaw M, Charvet L, Biagioni M.
Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, sham-controlled trial.Charvet LE, Dobbs B, Shaw MT, Bikson M, Datta A, Krupp LB.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Pediatric Teleneuromodulation - Completed

Current exploratory single site open label unblinded trial, will assess the feasibility of active tDCS in the home setting under caregiver and remote investigator supervision and direction. The study population will consist of 10 children between ages 8 - 17 years and 365 days with a history of a brain bleed or stroke.

An estimated 3.6 per 1,000 births in the United States are affected by stroke or brain bleeds which can lead to Cerebral Palsy (CP), a developmental disorder associated with motor impairment. While, the majority of rehabilitation approaches focus on behavioral repetition to improve gait and upper extremity function, these therapies can require extensive practice times and extent of recovery is variable.

Home-based Transcranial Direct-current Stimulation (tDCS) for Prevention of Suicidal Ideation - Completed

One aim of the study is to examine the feasibility and acceptability of the home-based transcranial direct current stimulation (tDCS) apparatus and protocol (as well as the home-based tDCS sham protocol) for future use as an adjunctive treatment to reduce suicidality and suicidal ideation (SI) in adult patients after discharge from a psychiatric hospitalization for suicidal behavior (note, all participants will received best practices post discharge suicide prevention care; the tDCS/sham tDCS protocols are adjunctive). The hypothesis is that home-based tDCS will be successfully implemented, appropriately applied, well tolerated, and produce high user satisfaction, and participants will be unable to differentiate home-based tDCS from sham home-based tDCS.

More on Suicidal Ideation at:MedlinePlus

Sponsor
The University of Texas Health Science Center, Houston

Complete information at Clinical Trials.Gov

Selected References

Long term at-home treatment with transcranial direct current stimulation (tDCS) improves symptoms of cerebellar ataxia: a case report.Pilloni G, Shaw M, Feinberg C, Clayton A, Palmeri M, Datta A, Charvet LE.
Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis.Charvet L, Shaw M, Dobbs B, Frontario A, Sherman K, Bikson M, Datta A, Krupp L, Zeinapour E, Kasschau M.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain (Warriors) - Active, Not Recruiting

The Veteran population has been known to deal with co-morbid chronic pain and PTSD. As a result, they use healthcare services at a higher rate than those Veterans with pain or PTSD alone which leads to an amplified burden on healthcare systems. This study hypothesizes that our short-term therapy-focused treatment program coupled with tDCS administrations will aid in the reduction of chronic pain and PTSD symptoms. Secondly, the investigators intend to examine any relationships between BDNF reduction in reported pain and PTSD and related mental health symptoms. Subjects will be identified from the Emory Healthcare Veterans Program (EHVP-IOP) Veterans and Service members seeking psychiatric treatment for mental health issues including PTSD.

More on Depression at: MedlinePlus
More on Chronic Pain at: MedlinePlus

Sponsor
Emory University

Complete information at Clinical Trials.Gov

Selected References

Working memory training with tDCS improves behavioral and neurophysiological symptoms in pilot group with post-traumatic stress disorder (PTSD) and with poor working memory.Saunders N, Downham R, Turman B, Kropotov J, Clark R, Yumash R, Szatmary A.
A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management.Janice Jimenez-Torres G, Weinstein BL, Walker CR, Christopher Fowler J, Ashford P, Borckardt JJ, Madan A.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Improving Aphasia Using Electrical Brain Stimulation - Recruiting

Language and communication are essential for almost every aspect of human life, but for people who have aphasia, a language processing disorder that can occur after stroke or brain injury, even simple conversations can become a formidable challenge. Speech and language therapy can help people recover their language ability, but often requires months or even years of therapy before a person is able to overcome these challenges. This research will investigate non-invasive brain stimulation as a way to enhance the effects of speech and language therapy, which may ultimately lead to better and faster recovery from stroke and aphasia. The investigators hypothesize that participants with aphasia who receive speech and language therapy paired with active electrical brain stimulation will improve significantly more on a language comprehension task than those who receive speech and language therapy paired with sham stimulation.

Virtual Neuro-Navigation System for Personalized Community Based TMS - Recruiting

Under this phase I study, Soterix Medical would develop an initial version of the software ("TMSMap") and CU would perform feasibility testing on patients with treatment resistant depression.

RCT of At-Home tDCS for Depression in Pregnancy - Recruiting

This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum

Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS - Completed

COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue) and neurological complications after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation high definition (HD-tDCS) have been proposed to minimize functional and structural impairments. Recently, I electroencephalogram (EEG) has been used as predictor of HD-tDCS effectiveness in diverse neurological populations. However, evidences about this tool utilization as efficacy predictor of tDCS in COVID-19 people rest inconclusive. Thereby, our objective is to evaluate HD-tDCS efficacy on fatigue, pain and functional capacity of patients with COVID-19 chronic.

EEG as Predictor of HD-tDCS Effectiveness in Long COVID-19 - Recruiting

COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue) and neurological complications after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation (tDCS) have been proposed to minimize functional and structural impairments. Electroencephalogram (EEG) has been used in this population to assess electrophysiological changes in the brain. However, evidences about EEG utilization as efficacy predictor of tDCS in COVID-19 people rest inconclusive.Our objective is to evaluate EEG as neurobiological predictor marker of tDCS efficacy on fatigue, pain, quality of life, self-efficacy and functional capacity in the chronic phase of COVID-19.

Frontal Stimulation to Modulate Threat Sensitivity in Anxious Depression - Completed

Over 50% of patients with major depressive disorder (MDD) do not respond to initial treatment and relapse is common. In particular, comorbid depression and anxiety disorders are associated with more treatment resistance. Thus, there is a great need for novel, more targeted treatments. Transcranial direct current stimulation (tDCS) is a novel intervention that can be used to causally target neural excitability and plasticity in brain regions/circuits implicated in regulating mood and anxiety and emerging evidence suggests that it reduces threat sensitivity. Here the investigators propose to use tDCS to target threat sensitivity as a core symptom of anxious depression to determine if the investigators can engage the neural circuits that are treatment targets.

More on Depression at: MedlinePlus
More on Anxiety at: MedlinePlus

Sponsor
Laureate Institute for Brain Research, Inc.

Collaborators:
National Institute of General Medical Sciences (NIGMS)

Complete information at Clinical Trials.Gov

Selected References

Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice.Charvet LE, Shaw MT, Bikson M, Woods AJ, Knotkova H.
Efficacy and neurophysiological predictors of treatment response of adjunct bifrontal transcranial direct current stimulation (tDCS) in treating unipolar and bipolar depression.Lin, Y. Y., Chang, C. C., Huang, C. C., Tzeng, N. S., Kao, Y. C., & Chang, H. A.
Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study.Goerigk S, Cretaz E, Sampaio-Junior B, Vieira ÉLM, Gattaz W, Klein I, Lafer B, Teixeira AL, Carvalho AF, Lotufo PA, Benseñor IM, Bühner M, Padberg F, Brunoni AR.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

Transcranial Alternating Current Stimulation (tACS) in Aphasia - Recruiting

This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke as well as healthy language functions.

Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms - Recruiting

The purpose of this study is to determine the effects of active transcranial direct current stimulation (tDCS) paired with active mindfulness-based meditation (MBM) on clinical pain,osteo arthritis (OA)-related clinical symptoms, physiopsychological pain processing and participant satisfaction with treatment in patients with knee OA.

Combine Mirror Therapy and tDCS on CPSP - Completed

Central poststroke pain (CPSP) refers to the symptom of pain arising after a stroke. Patients with CPSP often complain of various painful or unpleasant sensation. Feelings of pain may interfere with sleep and hugely affect the patients' quality of life. Non-invasive brain stimulation, such as transcranial direct current stimulation (tDCS), is an emerging nonpharmacological treatment and has been shown to have promising pain reduction effects for patients with CPSP. Mirror therapy (MT), on the other hand, is a contemporary approach that has often been used to facilitate upper extremity motor recovery in patients with stroke. MT has been shown to be effective in ameliorating sensory deficits and reducing shoulder pain. To date, no study has determined whether combining MT with tDCS could reduce pain in patients with CPSP. The goal of this study is to determine the effect of combining MT and tDCS on pain, sensation, motor function, and quality of life in people with CPSP.

The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study - Recruiting

This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.

Temporal Interference and Depression (TI) - Not yet recruiting

In this trial, 30 participants meeting the diagnostic criteria for Major Depressive Disorder (MDD) will be randomized to receive 10 sessions of 130 Hz Temporal Interference (TI) delivered daily for 30 minutes, or 10 sessions of sham stimulation. The investigators will collect metrics of SCC target engagement using the resting-state fMRI and EEG technologies, and determine feasibility, tolerability, safety, and therapeutic efficacy of TI stimulation in MDD. The results of this trial will inform the TI technology as a therapeutic tool for network-based psychiatric disorders, including MDD, and be vital for the design and development of a large-scale randomized-controlled trial.

More on Depression at: National Institute of Mental Health

Sponsor
Unity Health Toronto

Collaborators:
Beth Israel Deaconess Medical Center
Northeastern University
Centre for Addiction and Mental Health
Charite University, Berlin, Germany
Soterix Medical
Ryerson University

Complete information at Clinical Trials.Gov

Selected References

Classification of methods in transcranial electrical stimulation (tES) and evolving strategy from historical approaches to contemporary innovations.Guleyupoglu B, Schestatsky P, Edwards D, Fregni F, Bikson M.
Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields.Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N8, Tsai L, Pascual-Leone A, Boyden ES.

Caution! Investigational Device. Federal (or United States) law limits device to investigational use.

MEGA-IOM

Soterix Medical Clinical Trials

A clinical trial is a research study conducted to answer specific questions about new treatments, or to investigate new ways of using known treatments.

Featured Clinical Trials

A Study of Cerebral Perfusion With tDCS in Chronic Hypoperfusion - Not yet recruiting

Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation (NIBS4CIPN) - Not yet recruiting

Extending taVNS Paired With Infant CIMT Into a Home-Based Setting - Completed

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge - Recruiting

Using tDCS in Speech-based Stroke Rehabilitation - Recruiting

Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training - Completed

Neuromodulation of Cognition in Older Adults - Completed

Accelerating Motor Learning in Pediatrics (AMPED) - Completed

Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain - Completed

Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS) - Active, Not Recruiting

TDCS for Cocaine Addiction Craving - Completed

Combining tDCS and Neurorehabilitation to Treat Age-related Deficits of Mobility and Cognition: UPfront Walking Study - Completed

Transcranial Direct Current Stimulation for Post-stroke Fatigue - Recruiting

Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy - Completed

Transcranial Stimulation for Physiotherapy Optimisation - Chronic Low Back Pain (STOP-CLBP) - Recruiting

Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis - Completed

Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis - Completed

Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation - Recruiting

Amplitude Titration to Improve ECT Clinical Outcomes - Recruiting

Pain Relief for OsteoArthritis Through Combined Treatment (PROACT) - Recruiting

Electrical Neuromodulation for Focal Epilepsy - Not yet recruiting

Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA) - Completed

Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset - Recruiting

Stimulation for Perinatal Stroke Optimizing Recovery Trajectories (SPORT) - Completed

Transcranial Direct Current Stimulation (tDCS) Therapy in Major Depression - Completed

HD-tDCS as a Treatment for Chronic Tinnitus - Completed

Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults - Completed

Speech and Voice Outcomes Following HD-tDCS Over the Left SMA - Not yet recruiting

Transcranial Direct Current Stimulation (tDCS) Augments the Effects of Gamified, Mobile Attention Bias Modification - Completed

Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) - Recruiting

Transcranial Direct Current Stimulation for Gait Recovery Following Stroke (TransGait) - Recruiting

Trial of Enhanced Neurostimulation for Anorexia (TRENA) - Recruiting

Electroconvulsive Therapy Amplitude Titration - Completed

The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa - Recruiting

Effect of Speech Therapy in Combination With Non-invasive Brain Stimulation on Speech of Patients With Parkinson's Disease - Recruiting

Transcranial Alternating Current Stimulation (tACS) for the Recovery of Phonological Short-Term Memory in Patients With Aphasia After Stroke - Recruiting

tDCS and Glucose Uptake in Leg Muscles - Completed

Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias - Completed

HD-tDCS to Modulate Connectivity - Recruiting

Altering Multitasking Behavior Using Low Current Brain Stimulation - Active, Not Recruiting

HD-tDCS for Phonological Impairment in Aphasia - Completed

Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis - Completed

Treatment of COVID-19 Post-acute Cognitive Impairment Sequelae With tDCS (PASC) - Completed

AMPLIFY Study: Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After SCI - Recruiting

The Use of Transcranial Direct Current Stimulation (tDCS) in Adults With Developmental Disabilities (tDCS-RIADD) - Recruiting

Rapid Acting Transcranial Magnetic Stimulation - Recruiting

taVNS for Persistent Symptoms From Lyme Disease - Active, Not recruiting

HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults - Completed

Effects of Transcranial Direct Current Stimulation (tDCS) on Language - Recruiting

Transcranial Direct Current Stimulation for Improving Gait Training in Stroke - Completed

Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty - Completed

tDCS to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis - Completed

Tolerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors (TOPSS) - Completed

Cognitive Enhancement in Depression (The COG-D Study) - Recruiting

Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy - Completed

Treatment Outcomes With tDCS in Post-Stroke Aphasia - Recruiting

Transcranial Alternating Current Stimulation in Patients With Disorders of Consciousness - Recruiting

Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia - Completed

Home-Based tDCS in Children With ADHD: A Randomized, Sham-Controlled tDCS and fNIRS Study - Unknow Status

Non-invasive Neustimulation and Respiratory Rehabilitation - Recruiting

Barriers to Substance Use Disorder Recovery - Completed

INSIGHT, A Comprehensive, Multidisciplinary Brain Training System (INSIGHT) - Completed

Post-stroke Fatigue, Inflammation, tDCS - Completed

Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation - Recruiting

Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19 - Completed

Non-invasive Brain Stimulation of the Prefrontal Cortex in Substance Use Disorders - Recruiting

Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response - Recruiting

SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults - Completed

Effect of Noninvasive Electrical Brain Stimulation on Memory at Different Times of Day in Younger and Older Adults - Completed

Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study - Completed

Modulating Prospective Memory in Older Adults With Non-invasive Brain Stimulation - Completed

Study of the Synergistic Effects of Biofeedback and Transcranial Electrical Stimulation in Anxio-depressive Disorders - Completed

Open Label Extension Study of tDCS Plus Guided Imagery for Women With Chronic Pelvic Pain (CPP) - Withdrawn

Study of the Acute Effects of Guided Imagery and tDCS on Pain Levels in Women With Chronic Pelvic Pain - Withdrawn

Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients - Completed