MEGA-IOM

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

The Soterix Medical 1X1 CT device is being used in the study.The Soterix transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system is the most advanced and customizable stimulation for true double-blind control trials. Each 1x1-CT unit is shipped configured to a specific trial or set of trials, including custom accessories, and relevant features to ensure the highest standards of reproducibility and safety, all without breaking subject’s or operator’s blind. - 1X1 CT.

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.

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

More on Amyotrophic Lateral Sclerosis (ALS)

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.

Sponsor
University of Illinois at Chicago

Collaborator
University of Chicago

More on Anterior Cruciate Ligament Reconstruction

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.

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.

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.

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.

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

More on Soterix Medical Remote tDCS Platforms

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

Sponsor
The University of New South Wales

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.

tDCS-LTE Major Depression Disorder Trial - Completed

Soterix Medical Inc. has received FDA Investigational Device Exception (IDE) to launch a trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD). The tDCS-LTE trial for MDD leverages Soterix Medical proprietary technology supporting reliable home-based transcranial Direct Current Stimulation (tDCS) including the single-use SNAPpad™ electrodes that ensure clean and tolerated therapy at-home, and the ElectraRx™ digital healthcare platform that provides caregivers ongoing insight on patient response and full control of ongoing therapy.

Sponsor
Soterix Medical

Collaborator
NYU Langone Health

Selected References

Trial of Electrical Direct-Current Therapy Versus Escitalopram for Depression. Andre R Brunoni , Adriano H Moffa, Bernardo Sampaio-Junior, Lucas Borrione, Marina L Moreno, Raquel A Fernandes, Beatriz P Veronez, Barbara S Nogueira, Luana V M Aparicio, Lais B Razza, Renan Chamorro, Luara C Tort, Renerio Fragua, Paulo A Lotufo, Wagner F Gattaz, Felipe Fregn, Isabela M Benseñor, ELECT-TDCS Investigators. N Engl J Med. 2017 Jun 29;376(26):2523-2533.

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.

The Soterix Medical tSDCS System is being used in the study. The Soterix Medical tsDCS System is the only stimulator which has been specifically designed for transcutaneous Spinal Direct Current Stimulation, from cervical to lumbar targets. More on Soterix tSDCS.
Access complete trial information here.

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

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 understand how tDCS works, how it can be optimized, and if it can be used as an effective intervention for reducing depressive symptoms.

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.

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

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

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

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

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)

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

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

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.

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

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

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

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

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

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

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

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

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

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)

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