Major Depressive Disorder (MDD)REACH-tDCSNCT06976697
Home-Based tDCS Treatment Of Major Depressive Disorder
A study testing Transcranial direct current stimulation in people with Major Depressive Disorder (MDD), run by Sooma Medical Inc at 1 site in United States.
Trial summary
The REACH-tDCS study will evaluate the safety and efficacy of a noninvasive, at-home self-administered Sooma tDCS brain stimulation treatment for Major Depressive Disorder. The study uses randomized, blinded, placebo controlled design. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2025to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22 - 70 years of age
- Diagnosis of Unipolar MDD (DSM-V)
- PHQ-9 score of ≥12 AND MADRS score of ≥ 20 at baseline
- Antidepressant medication ongoing
- If in psychotherapy, have maintained stable psychotherapy
- Have access to a smartphone or other device running Android 7.0+ or iPhone Operating System (iOS) 13+
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- Be under the care of a psychiatrist or a primary care physician
- Allow communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years
- Provide the name and contact of at least two adult persons who reside within a 60-minute drive of the patient's residence.
- Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
- Be willing and able to comply with all study procedures
- Agree to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study
- Be able to understand, speak, and read English sufficient for the completion of trial assessments
Who cannot join
- Current state of mania or psychosis, or have a history of mania or psychosis.
- Treatment resistant depression.
- Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.
- Be currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria or have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation.
- Have moderate or greater suicidality risk, or an attempt of suicide during lifetime or any previous hospitalization for suicidal behavior.
- Diagnosis of sleep apnea with prescribed treatment (unless they are on CPAP treatment and are compliant with treatment) or a diagnosis of insomnia that is unrelated to depression, as determined by the investigator.
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- Have any structural lesion or any neurocranial defect or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results, as determined by the investigator.
- Have any implant in the brain (e.g., DBS) or neurocranium, or any other active implantable medical device anywhere in the body (e.g. pacemaker, insulin pump).
- Have a history of epilepsy or seizures.
- Have shrapnel or any ferromagnetic material in the head.
- Have any disorder that would impair the ability to complete the study questionnaires.
- Have been diagnosed with autism spectrum disorder.
- Have an alcohol use disorder or substance use disorder (past 12 months).
- Have a cognitive impairment (including dementia).
- medications that affect cortical excitability, as determined by the investigator.
- Have ever taken esketamine / ketamine for treatment of depression.
- Are currently admitted or have ever been admitted to a dedicated psychiatric ward for depression for a period of more than 24 hours.
- Have ever been diagnosed with obsessive-compulsive disorder (OCD) or bipolar type 1 or 2 disorder.
- Be diagnosed with PTSD, agoraphobia, anorexia or bulimia, panic or personality disorder, with active symptoms, based on the investigator's judgment.
- Have any history of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues.
- Be currently experiencing or have a history of intractable migraines.
- Be a chronic nicotine user.
- Be currently pregnant or breastfeeding or planning to become pregnant or breastfeed any time during the study, or lack a medically acceptable method of contraception in females with child-bearing potential.
- Be currently incarcerated.
- Be participating concurrently in another clinical investigation or have participated in a clinical investigation within the last 90 days or intend to participate in another clinical investigation during the study.
- Have a hairstyle or hair type, such as very thick hair or voluminous hairstyle, that would prevent wearing of the treatment cap tightly enough on the head that the electrodes are held close to the scalp.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Curavit Clinical Research (virtual study site)
Boston, Massachusetts, 02116
Trial Coordinator, 844-212-3083, reach@lindushealth.com
About this study
Official title: Safety And Efficacy of Remotely Supervised Home-Based tDCS Treatment Of Major Depressive Disorder
The REACH-tDCS study will evaluate the safety and efficacy of a noninvasive, at-home self-administered Sooma tDCS brain stimulation treatment for Major Depressive Disorder. The study uses randomized, blinded, placebo controlled design. The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period.
Read the detailed description
The study stages include: screening, eligibility evaluation, randomization to active or sham arm (1:1), the first treatment period (weeks 1-10) with sham-control and the optional open-label phase (weeks 11-20) where all treatments will be in active mode.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- Depression, Brain stimulation, Brain, Sooma, tDCS, tES
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
In tDCS treatment session electrical current (2 mA) is applied for 30 minutes through two electrodes placed on top of scalp to modulate neural activity.
Sham transcranial direct current stimulationDevice
Sham treatment mimics the active device use and the experiences from the active stimulation while minimizing active effects.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Not described Receives: Device: Transcranial direct current stimulation |
| Sham treatment | Sham comparator | Not described Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS: change from baseline
Mean change in depressive symptoms, measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score, from baseline to week 10. MADRS ranges from 0 to 60, with higher scores indicating more severe depression.
Measured: 10 weeks from treatment initiation.
Secondary outcomes (9)
MADRS: rate of response
Rate of response defined as the percent of subjects achieving at least 50% reduction from baseline in their MADRS at week 10.
Measured: 10 weeks from treatment initiation.
MADRS: rate of remission
Rate of remission remission defined as the percent of subjects with MADRS score ≤ 10 at week 10.
Measured: 10 weeks from treatment initiation.
HAM-D17: change form baseline
Mean change in depressive symptoms, measured by Hamilton Depression Rating Scale (17-items) (HAM-D17), from baseline to week 10. HAM-D17 ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: 10 weeks from treatment initiation.
HAM-D17: rate of response
Rate of response defined as the percent of subjects achieving at least 50% reduction from baseline in their HAM-D17 at week 10.
Measured: 10 weeks from treatment initiation.
HAM-D17: rate of remission
Rate of remission defined as the percent of subjects with HAM-D17 score ≤ 7 at week 10.
Measured: 10 weeks from treatment initiation.
PHQ-9: change from baseline
Mean change in depressive symptoms, measured by Patient Health Questionnaire-9 (PHQ-9) total score, from baseline to week 10. PHQ-9 ranges from 0 to 27, with higher scores indicating more severe depression.
Measured: 10 weeks from treatment initiation.
PHQ-9: rate of response
Rate of response defined as the percent of subjects achieving at least 50% reduction from baseline in their PHQ-9 at week 10.
Measured: 10 weeks from treatment initiation.
PHQ-9: rate of remission
Rate of remission, defined as the percent of subjects with PHQ-9 score ≤ 4 at week 10.
Measured: 10 weeks from treatment initiation.
CGI-I
The clinical global impression - improvement scale (CGI-I) is a 7-point scale allowing the clinical rater to assess how much the patient's overall condition has improved or worsened since starting the intervention (1. very much improved, 2. much improved, 3. minimally improved, 4. no change, 5. minimally worse, 6. much worse, 7. very much worse).
Measured: 10 weeks from treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start27 Jun 2025
- Primary completion10 Oct 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sooma Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Reist, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976697
- Sponsor's protocol ID
- SM-001
- Acronym
- REACH-tDCS
- Status last verified
- Mar 2026
- First submitted
- 7 May 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The IPD used in the results of the publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy of Remotely Supervised Home-Based tDCS Treatment Of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06976697
- Acronym / sponsor ID
- REACH-tDCS / SM-001
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Depression, Brain stimulation, Brain, Sooma, tDCS, tES
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sooma Medical IncIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The REACH-tDCS study will evaluate the safety and efficacy of a noninvasive, at-home self-administered Sooma tDCS brain stimulation treatment for Major Depressive Disorder. The study uses randomized, blinded, placebo controlled design. The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period.
Detailed description
The study stages include: screening, eligibility evaluation, randomization to active or sham arm (1:1), the first treatment period (weeks 1-10) with sham-control and the optional open-label phase (weeks 11-20) where all treatments will be in active mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: Transcranial direct current stimulation |
| Sham treatment | Sham comparator | Device: Sham transcranial direct current stimulation |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 22 - 70 years of age
- Diagnosis of Unipolar MDD (DSM-V)
- PHQ-9 score of ≥12 AND MADRS score of ≥ 20 at baseline
- Antidepressant medication ongoing
- If in psychotherapy, have maintained stable psychotherapy
Key exclusion criteria (26 listed)
- Current state of mania or psychosis, or have a history of mania or psychosis.
- Treatment resistant depression.
- Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.
- Be currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria or have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation.
- Have moderate or greater suicidality risk, or an attempt of suicide during lifetime or any previous hospitalization for suicidal behavior.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationIn tDCS treatment session electrical current (2 mA) is applied for 30 minutes through two electrodes placed on top of scalp to modulate neural activity. | Device | Active treatment |
| Sham transcranial direct current stimulationSham treatment mimics the active device use and the experiences from the active stimulation while minimizing active effects. | Device | Sham treatment |
Primary outcome
MADRS: change from baseline
Time frame: 10 weeks from treatment initiation.
Mean change in depressive symptoms, measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score, from baseline to week 10. MADRS ranges from 0 to 60, with higher scores indicating more severe depression.
9 secondary outcomes
MADRS: rate of response
Time frame: 10 weeks from treatment initiation.
MADRS: rate of remission
Time frame: 10 weeks from treatment initiation.
HAM-D17: change form baseline
Time frame: 10 weeks from treatment initiation.
HAM-D17: rate of response
Time frame: 10 weeks from treatment initiation.
HAM-D17: rate of remission
Time frame: 10 weeks from treatment initiation.
PHQ-9: change from baseline
Time frame: 10 weeks from treatment initiation.
PHQ-9: rate of response
Time frame: 10 weeks from treatment initiation.
PHQ-9: rate of remission
Time frame: 10 weeks from treatment initiation.
CGI-I
Time frame: 10 weeks from treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- More information on this trial can be found on the Study Website.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The IPD used in the results of the publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Curavit Clinical Research (virtual study site)
Boston, United States
Christopher Reist, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Major Depressive Disorder (MDD), run by Sooma Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS: change from baseline (time frame: 10 weeks from treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.