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.

In most cases, the therapies and devices investigated in clinical trials are not approved by Regulatory Agencies (such as the Food and Drug Administration (FDA) in the United States), and the benefits and risks of treatment are under investigation. Clinical trials are used to determine whether new treatments are safe and effective. The clinical testing of experimental treatments or devices is generally done in three phases, each successive phase involving a larger number of people.

The knowledge gained from years of clinical trials regarding the safety and efficacy of new treatments or devices ultimately may allow medical device companies to offer new and better options to patients. Soterix Medical Inc. was founded to support clinical trials of non-invasive neuromodulation technologies such as tDCS, tDCS-LTE, and HD-tDCS.

At anytime Soterix Medical is conducting numerous clinical trials in a variety of therapeutic areas. Content on this website is for information purposes only. Further information about clinical trials, such as the condition and intervention being studied, the phase, the study type, location, recruitment status and more is available at government regulatory agency registers and the US National Institutes of Health clinical trials website. To view those being conducted by Soterix Medical listed on the US National Institutes of Health clinical trials website

Featured Clinical Trials

Augmenting Cognitive Training in Older Adults (ACT)

Trial will assess the individual and combined impact of pairing cognitive training with tDCS in adults (65-89 years).

Soterix Medical 1x1 Clinical Trials (CT) device using Limited Total Energy (LTE™) technology is being used in the study.

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

This study evaluates the application of non-invasive brain stimulation in the treatment of Mild Cognitive Impairment (MCI) in adults aged 55-85.

Soterix Medical 1x1 tES device is being used in the study.

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

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

Soterix Medical 1x1 tDCS device is being used in the study.

MARt-Depression Trial

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.

Soterix Medical 1x1 tDCS mini-CT device is being used in the study

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

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.

Soterix Medical 1x1 tDCS device is being used in the study

Completed

tDCS for the Treatment of Bipolar Depression

Soterix Medical 1x1 Clinical Trials device with Limited Total Energy (LTE) to be used in a trial to study the antidepressant effects of tDCS in bipolar disorder.

tDCS and Talking Therapy for Aphasia

Hunter College of The City University of New York will investigate the use of Soterix Medical 1x1 tDCS (transcranial direct current stimulation) in conjunction with speech-language therapy, for the improvement of language production in stroke survivors with aphasia.

Completed

Phase III Clinical Trial for major depressive disorder

Trial will compare Soterix Medical tDCS-LTE™ technology against a fully dosed, effective antidepressant Escitalopram oxalate (Lexapro). Recruitment ongoing.
Soterix Medical 1×1 Clinical Trials (CT) device using Limited Total Energy (LTE™) technology is being used in the study.

Completed

Effects of tDCS on Motor Learning in Children With Cerebral Palsy (CP)

Trial will 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.

Cognitive Stimulation Study (CogStim)

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. Soterix Medical 1×1 tDCS device is being used in this study.

Completed

Neuropathic Symptoms Following Burn Injury Trial

Spaulding Rehabilitation Hospital and the US Department of Education will investigate the effects of Soterix Medical 1x1 transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System.

Completed

Phase II Fibromyalgia Trial

Follow up Phase II, HD-tDCS clinical trial underway for fibromyalgia at Harvard Medical School and Spaulding Rehabilitation Hospital, and in conjunction with Elminda Corporation. Exclusive Soterix 4x1 HD-tDCS being used.

Completed

Abdominal pain in patients with chronic pancreatitis Clinical Trial

This study is testing whether the addition Soterix Medical 1x1 transcranial direct current stimulation (tDCS) when combined with meditation helps decrease the abdominal pain in patients with chronic pancreatitis.

Completed

Corneal Pain Clinical Trial

Study focused on investigating effect of tDCS on chronic corneal pain as well as changes in thought processing as compared to healthy controls. Soterix 1×1 Device is being used.

Completed

Stroke Recovery Clinical Trial

Study focused on evaluating the effect of a combination of robotic arm therapy and transcranial Direct Current Stimulation for greater functional recovery after stroke.

Completed

Depression Clinical Trial

For the most comprehensive tDCS trial to-date, researchers selected the most advanced tDCS device and the only system optimized for clinical trials – The Soterix Medical 1x1-CT.

Completed

Pediatric Epilepsy Trial

Epilepsy Foundation awards a New Therapy Grant for a clinical trial of High-Definition tDCS in pediatric epilepsy. Dr. Alexander Rotenberg will lead a team of clinical investigators including at BCH and Harvard Medical School.

Completed

Stroke Rehabilitation Trial

NIH grants Burke Medical Research Institute $3m to conduct the most controlled trial of tDCS for stroke rehabilitation to date. The Soterix Medical 1x1 platform is the most advanced and the industry standard for tDCS clinical trials for rehabilitation.

Completed

Down Syndrome Trial

Soterix Medical Inc. receives FDA Clinical Trial IDE for High-Definition tDCS (HD-tDCS) to improve IQ in pediatric Down syndrome. HD-tDCS is the only non-invasive, brain targeted, and low-intensity technology designed to promote neuroplasticity.

Completed

Pediatric Hemiparesis Trial

Dr. Bernadette Gillick's Pediatric Rehabilitation Laboratory is supported by the NIH and University of Minnesota Clinical and Translational Science Institute to investigate the use of a form of tDCS for interventions in rehabilitation for children. Subject specific analysis with Soterix Medical Neurotargeting™ will guide current to brain cells in the injured part of the brain.

Completed

Fibromyalgia Clinical Trial

HD-tDCS clinical trial underway for fibromyalgia at Harvard Medical School and Spaulding Rehabilitation Hospital, Boston.

Completed

Stroke Rehabilitation Clinical Trial

NIH grants Soterix a Phase-1 STTR grant to develop HD-tDCS for stroke rehabilitation. The first technology capable of delivering therapeutic direct current to target brain regions involved in functional recovery.

tDCS to Reduce Craving in Cocaine Addiction - Recruiting

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.

This study will recruit individuals with a diagnosis of cocaine use disorder (per DSM-5 criteria) who are receiving treatment for their substance use disorder . Patients will be randomly assigned to receive either active or sham (placebo) tDCS. Participants will receive 20 minutes of stimulation per tDCS day, three days per week for five weeks.

Interviews and neuropsychological testing will be conducted, and self-reported drug craving and addiction severity questionnaires will be used. Follow up cognitive and behavioral assessments will be conducted over a period of 12 months post tDCS stimulation.

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. More on Soterix Medical 1X1 mini-CT.
Access complete clinical trial information here

More on Cocaine Addiction from the National Institute on Drug Abuse

Sponsor
Soterix Medical

Collaborator
Icahn School of Medicine at Mount Sinai

Selected References

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

Robot and tDCS Based Proprioceptive Rehabilitation After Stroke (Phase 2) - Recruiting

Proprioceptive deficits are common following stroke, yet current evidence-based approaches for rehabilitating proprioception are limited. Robotic rehabilitation and transcranial direct current stimulation (tDCS) are two promising technologies/techniques that can potentially be used to treat these deficits. This study's purpose is to determine whether robotic rehabilitation, specifically targeted at proprioception, has the capacity to improve proprioception in a chronic stroke population. Furthermore, it is interested in whether tDCS is able to enhance any potential improvements in proprioception as a result of robotic rehabilitation.

It is hypothesized that individuals receiving a combination of robotic rehabilitation and tDCS will show greater proprioceptive improvements than those just receiving robotic rehabilitation.

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 Medical 1×1 tDCS device.
Access complete clinical trial information here

More on Proprioceptive Senses from the NCBI

More on Stroke from the CDC

Sponsor
University of Calgary

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 - Recruiting

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 clinical trial information here

More on Spinal Cord Injury (SCI) from MedlinePlus

Sponsor
University of Florida

Collaborators
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.

Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS) - Recruiting

The proposed study will test the feasibility and tolerability of transcranial direct current stimulation (tDCS) added to a cognitive remediation program in n=100 adults. For 60 cognitive remediation sessions, participants will receive 20 minutes of active tDCS stimulation (up to 4.0 mA, dorsolateral prefrontal cortex or montage dependent on specific area of deficit) while they complete the cognitive training tasks.

To meet this study's objectives, investigators will focus specifically on working memory (WM) in both training and outcome.

The Soterix Medical 1X1 mini-CT 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. More on Soterix Medical 1x1 mini-CT.
Access complete clinical trial information here

More information on Neurological Disorders from MedlinePlus

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

Sponsor
NYU Langone Health

Selected References

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) - Recruiting

Phantom limb pain (PLP) belongs to a group of neuropathic pain syndromes that is characterized by pain in the amputated limb. As in other chronic pain syndromes, chronic Phantom limb pain (PLP) is often difficult to treat; showing to be resistant to classical pharmacological and surgical treatment approaches.

Transcranial direct current stimulation (tDCS,Soterix ©) is a powerful and non-invasive technique of brain stimulation that is known to significantly modulate plasticity and alleviate chronic pain in various syndromes.

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).

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 Phantom Limb Pain (PLP) from MedlinePlus

Sponsor
Spaulding Rehabilitation Hospital

Collaborator
Massachusetts Eye and Ear Infirmary

Selected References

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 - Recruiting

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.

The Soterix Medical 1X1 mini-CT 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. More on Soterix Medical 1x1 mini-CT.
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.

Altering Multitasking Behavior Using Low Current Brain Stimulation - 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.

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

Sponsor
Tufts University

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

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

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.

The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA)

The Soterix Medical 1X1 mini-CT 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. More on Soterix Medical 1x1 mini-CT.
Access complete clinical trial information here

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

Sponsor
NYU Langone Health

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

Neuromodulation of Cognition in Older Adults: The Stimulated Brain Study - Recruiting

The current study will investigate methods for enhancing cognitive training effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. Age-related cognitive decline represents a major concern for public health.

Recent research suggests that cognitive training in older adults can improve cognitive performance, with effects lasting up to 10 years. An adaptive pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training (CT) 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 enhances neural plasticity when paired with a training task. The study will compare changes in cognitive and brain function resulting from CT and CT combined with tDCS .

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 Medical 1x1 mini-CT.
Access complete clinical trial information here

More about Aging and Cognitive Function from the Cleveland Clinic

Sponsor
University of Florida

Collaborator
National Institute on Aging (NIA)

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

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.

Participants will include thirty older adults who demonstrate evidence of frontal/executive impairment. Participants will be randomized to one of three groups: 1) standard walking neurorehabilitation with sham tDCS ('standard/sham' group), 2) complex walking neurorehabilitation with sham tDCS ('complex/sham' group), or 3) complex walking neurorehabilitation with active anodal tDCS ('complex/active' group).

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 about Aging and Cognitive Function from the Cleveland Clinic

More about Aging, Physical Activity and Cognition from the National Institute on Aging

Sponsor
University of Florida

Collaborator
National Institute on Aging (NIA)

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

Step-Down Neurostimulation to Maintain Response After Repetitive Transcranial Magnetic Stimulation (rTMS) Using Transcranial Direct Current Stimulation (tDCS): The START Study - Recruiting

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.

The Soterix Medical 1X1 mini-CT 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. 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 1x1 mini-CT.
Access complete clinical trial information here

Sponsor
Centre for Addiction and Mental Health

Collaborator
University Health Network, Toronto

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

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

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).

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. More on Soterix Medical 1x1 mini-CT.
Access complete clinical trial information here

More about Osteoarthritis from the Centers for Disease Control and Prevention

Sponsor
The University of Texas Health Science Center, Houston

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

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

Transcranial Direct Current Stimulation (tDCS) is the safest and most accessible, non-invasive brain stimulation technique available for testing causal links between different brain regions and functions, by manipulating cognitive abilities. By identifying key experimental factors that can improve the reliability and robustness of stimulation effects on cognitive performance in different age groups, this project should lead to the widespread adoption of these design features in future applications.

The study will investigate the extent to which tDCS to dorsolateral prefrontal cortex (or dlPFC) impacts recollection accuracy and working memory performance as a function of time-of-day in younger and older adults. Moreover, this study will test the extent that tDCS to dlPFC impacts memory performance by impacting information-specific processes and/or cognitive control processes that operate across different types of information, thereby informing basic theories of how dlPFC contributes to memory in younger and older adults.

The Soterix Medical transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system device 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

Sponsor
University of Chicago

collaborator
National Institute on Aging (NIA)

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

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

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.

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. The investigators will explore how developmental plasticity determines function and response to neuromodulation therapy. This patient oriented effort will advance personalized, precision medicine in pediatric neurorehabilitation to improve outcomes for disabled children and their families.

The Soterix Medical 1×1 tDCS device 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 about Cerebral Palsy fromthe Centers for Disease Control and Prevention

Sponsor
University of Calgary

collaborators
University of Alberta
Holland Bloorview Kids Rehabilitation Hospital
The Hospital for Sick Children

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

Transcranial Direct Current Stimulation to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis - Recruiting

The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on neuropathic pain and fatigue in people with Multiple Sclerosis (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. It is hypothesized that there will be less neuropathic pain and increased fatigue resistance after the tDCS sessions in people with MS.

The Soterix Medical 1×1 tDCS device 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 about Cerebral Palsy fromNational Institute of Health

More information on Neuropathic Pain from thehttps://my.clevelandclinic.org/health/diseases/15833-neuropathic-pain

Sponsor
University of Iowa

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

Transcranial Direct Current Stimulation for the Treatment of Delirium - Recruiting

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.

The Soterix Medical 1×1 tDCS LTE device 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. Soterix Medical tDCS-LTE is a unique system that provides an additional safety margin, without compromising efficacy, when stimulating susceptible subjects. More on Soterix 1x1 tDCS LTE.
Access complete clinical trial information here

More information on Delirium from MedlinePlus

Sponsor
North Florida/South Georgia Veterans Health System

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

Guided Imagery and Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain - Recruiting

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 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.

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

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 session.

The Soterix Medical transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system device 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 - Recruiting

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.

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

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.

The Soterix Medical 1X1 mini-CT 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. More on Soterix Medical 1x1 mini-CT.
Access complete clinical trial information here

More about Osteoarthritis from the Centers for Disease Control and Prevention

Sponsor
The University of Texas Health Science Center, Houston

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- Recruiting

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

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.

For more information: tES

Selected References

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-Recruiting

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

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

Selected References

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- Recruiting

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

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

Selected References

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

MARt-Depression Trial- Recruiting

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

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

Selected References

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

Targeted Electrotherapy for Aphasia Stroke Rehabilitation –Recruiting

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. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.

More on Aphasia at: http://www.ninds.nih.gov/disorders/aphasia/aphasia.htm/

Sponsor
Soterix Medical

Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Georgetown University
University of North Carolina, Chapel Hill
The City College of New York
Medstar Research Institute
University of South Carolina

Complete information at Clinical Trials.Gov

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. For more information - MXN

Selected References

Press Release
Soterix Medical Inc. awarded $2.5M NIH grant to run Phase-2 Efficacy Trial to treat Aphasia after Stroke with HD-tDCS

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 –Recruiting

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) – Withdrawn

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) – Active, not recruiting

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 – Recruiting

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– Recruiting

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- Recruiting

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

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

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

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 (https://www.northwell.edu/)

Complete information at Clinical Trials.Gov (https://clinicaltrials.gov/ct2/show/NCT02661347)

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/1x1/Overview)

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)– Recruiting

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 (http://www5.usp.br/english/?lang=en)

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

Complete information at Clinical Trials.Gov (https://clinicaltrials.gov/ct2/show/NCT01894815)

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. For more information - (https://soterixmedical.com/1x1/ct)

Selected References

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

Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain– Active, not recruiting

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– Active, not recruiting

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.

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 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)

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 design information 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.

Effects of noninvasive brain stimulation in the form of tDCS (transcranial direct current stimulation) in conjunction with speech-language therapy.

Aphasia, commonly defined as impairment or loss of language functions, is a frequent and often chronic consequence of stroke, with detrimental effects on patient autonomy and health-related quality of life (HRQOL). The proposed study will compare the effects of transcranial direct current stimulation (tDCS) activating language centers in the left hemisphere, and tDCS inhibiting Broca's homologue in the Right Hemisphere, in right-handed individuals with chronic post-stroke aphasia. This study will provide information on the effects of tDCS, in conjunction with speech-language therapy, on aphasia rehabilitation. Learn more about Soterix tDCS devices.

Access more information on Aphasia here
Complete clinical trial information here

Sponsor
Hunter College

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.

Selected References

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

Phase 3 trial for Major Depressive Disorder that will compare Soterix Medical tDCS-LTE technology against a fully dosed, effective antidepressant Escitalopram oxalate (Lexapro)- Recruitment ongoing

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.

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
“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 researchers investigate a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). In a prior clinical trial with 120 patients with MDD, the investigators demonstrated that the combination of tDCS with sertraline 50mg/day had both increased and faster effects on depressive symptoms (Brunoni et al., JAMA Psychiatry, 2013). However, although the investigators suggested that tDCS vs. sertraline had similar efficacy, such comparison was compromised due to the low sertraline dose and also because the comparison of sertraline vs. placebo was not significant. 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 for ten weeks, randomizing 240 patients with MDD in a 3:3:2 ratio (less to placebo). 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. As secondary aims, the researchers will investigate putative biomarkers for tDCS response. This is important considering the large sample size of this study and also the paucity of tDCS studies - therefore, the identification of such biomarkers could generate new hypothesis for future studies and for tDCS' mechanisms of action. The biomarkers will be: genetic polymorphisms (BDNF, SLC6A4, THP1, 5HT2A); serum markers (BDNF); motor cortical excitability (cortical silent period, intracortical inhibition, intracortical facilitation); heart rate variability; and neuroimaging (structural volume of the dorsolateral prefrontal and anterior cingulate cortex, white matter tracts of the prefrontal cortex and posterior cingulate cortex connectivity). This project represents a novel research line in our Institution, and the investigators thereby propose the onset of a new center denominated C.I.N.A. (Interdisciplinary Center for Applied Neuromodulation) that will foment the use and development of projects using neuromodulation techniques. This new center will also interact with other centers on the fields of clinical research, neurosciences and neuropsychiatry.”

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 LTE™ and CT.

Selected References

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

Cognitive Stimulation Study (CogStim)

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.

Effects of High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Fibromyalgia pain (Phase 1) –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

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) –Ongoing

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 –Ongoing

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-Ongoing.

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.

Effects of rTMS and tDCS on Motor Function in Stroke– Active, not recruiting

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.

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 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.

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

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

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)

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.

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

More on Hemiparesis from the National Stroke Association

Sponsor
University of Minnesota - Clinical and Translational Science Institute.

Collaborator
Minnesota Medical Foundation

Selected References

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