RecruitingNot ApplicableNCT06976697

Home-Based tDCS Treatment Of Major Depressive Disorder

Safety And Efficacy of Remotely Supervised Home-Based tDCS Treatment Of Major Depressive Disorder


Sponsor

Sooma Medical Inc

Enrollment

200 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

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. The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a home-based brain stimulation treatment called tDCS (transcranial direct current stimulation) for people with major depression. The device delivers a very mild electrical current to the scalp using a headset and is used at home, while the study team monitors your progress remotely. **You may be eligible if...** - You are between 22 and 70 years old - You have been diagnosed with major depressive disorder (MDD) - Your depression symptoms are moderate to severe (PHQ-9 score at least 13, MADRS at least 20) - You are currently taking antidepressant medication - You have access to a smartphone (Android 7.0+ or iPhone iOS 13+) - You are under the care of a psychiatrist or primary care doctor - You can read and communicate in English **You may NOT be eligible if...** - You have a history of mania or psychosis - Your depression has not responded to multiple treatments (treatment-resistant depression) - You have ever attempted suicide or have moderate-to-high suicide risk - You have a metal implant in your head or brain, or a pacemaker - You have a history of epilepsy or seizures - You have previously had brain stimulation treatments (ECT, TMS, DBS, or tDCS) - You have untreated sleep apnea or insomnia unrelated to depression Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial direct current stimulation

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.

DEVICESham transcranial direct current stimulation

Sham treatment mimics the active device use and the experiences from the active stimulation while minimizing active effects.


Locations(1)

Lindus Health (virtual study site)

Boston, Massachusetts, United States

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NCT06976697


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