tDCS for Depression

(REACH-tDCS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sooma Medical Inc

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christopher Reist, M.D.

Principal Investigator

Eligibility Criteria

This trial is for individuals with Major Depressive Disorder who are looking for a noninvasive treatment. Participants will use the Sooma tDCS device at home and must be comfortable with video interviews and self-reporting. Specific inclusion or exclusion criteria details were not provided.

Inclusion Criteria

I am between 22 and 70 years old.

Allow communication between investigators/study staff and healthcare provider

Provide contact information for at least two adult persons within a 60-minute drive

Exclusion Criteria

Disorders impairing ability to complete study questionnaires

Alcohol use disorder or substance use disorder in the past 12 months

Current state of mania or psychosis, or history of mania or psychosis

Treatment Details

Interventions

• tDCS

Trial Overview The REACH-tDCS study tests the safety and effectiveness of Sooma tDCS, a brain stimulation device used at home to treat depression. It's compared against a sham (placebo) version in a randomized, blinded setup over 10 weeks plus an optional continuation.

Participant Groups

Group I: Active treatment Experimental Treatment 1 Intervention

Group II: Sham treatment Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Sooma Medical Inc

Lead Sponsor