Worldwide

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 theUS National Institutes of Health clinical trials website click here

Clinical Trials

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Fibromyalgia Clinical Trial

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

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.

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 (http://soterixmedical.com/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 (http://soterixmedical.com/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 (http://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 - (http://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.