Actively Recruiting
Home-Based tDCS Treatment Of Major Depressive Disorder
Led by Sooma Medical Inc · Updated on 2026-03-23
200
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Home-Based tDCS Treatment Of Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 22 to 70 years of age
- Diagnosis of Unipolar Major Depressive Disorder (DSM-V)
- PHQ-9 score of 12 or higher and MADRS score of 20 or higher at baseline
- Currently taking antidepressant medication
- If receiving psychotherapy, must have maintained stable psychotherapy
- Access to a smartphone or device running Android 7.0+ or iOS 13+
- Under the care of a psychiatrist or primary care physician
- Allow communication between study staff and healthcare providers from past two years
- Provide contact information for at least two adults living within 60 minutes of residence
- Able to provide voluntary, written informed consent
- Willing and able to comply with all study procedures
- Able to understand, speak, and read English sufficient for trial assessments
You will not qualify if you...
- Current or past history of mania or psychosis
- Treatment resistant depression
- Diagnosed with vitamin or hormonal deficiencies mimicking mood disorders
- Receiving other interventional therapies for MDD besides stable antidepressants or psychotherapy
- History of electroconvulsive therapy, transcranial magnetic stimulation, cranial electrotherapy stimulation, tDCS, deep brain stimulation, or other brain stimulation
- Moderate or greater suicidality risk, past suicide attempts, or hospitalization for suicidal behavior
- Sleep apnea with prescribed treatment unless compliant with CPAP, or insomnia unrelated to depression
- Structural brain lesions, neurocranial defects, or other abnormalities affecting safety or study participation
- Brain or neurocranial implants or active implantable medical devices elsewhere
- History of epilepsy or seizures
- Presence of shrapnel or ferromagnetic material in the head
- Disorders impairing ability to complete study questionnaires
- Diagnosis of autism spectrum disorder
- Alcohol or substance use disorder within past 12 months
- Cognitive impairment including dementia
- Medications affecting cortical excitability
- Previous treatment with esketamine or ketamine for depression
- Current or past admission to psychiatric ward for depression longer than 24 hours
- Diagnosed with OCD or bipolar type 1 or 2 disorder
- Diagnosed with PTSD, agoraphobia, anorexia, bulimia, panic or personality disorder with active symptoms
- History of myocardial infarction, coronary artery bypass graft, coronary heart failure, or other cardiac issues
- Current or past intractable migraines
- Chronic nicotine use
- Pregnant, breastfeeding, planning pregnancy during study, or lacking medically acceptable contraception if female with childbearing potential
- Currently incarcerated
- Participation in another clinical trial within last 90 days or concurrent participation
- Hairstyle or hair type preventing proper electrode contact during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lindus Health (virtual study site)
Boston, Massachusetts, United States, 02111
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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