NCT06976697

Home-Based tDCS Treatment Of Major Depressive Disorder

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sooma Medical Inc · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
DEVICE	Transcranial 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.
DEVICE	Sham transcranial direct current stimulation	Sham treatment mimics the active device use and the experiences from the active stimulation while minimizing active effects.

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-10-10
• Completion: 2026-12-23
• First posted: 2025-05-16
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study