Home-Based tDCS Treatment Of Major Depressive Disorder

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Sooma Medical Inc
Study ID
NCT06976697
Status
Recruiting
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Conditions

  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial direct current stimulation — DEVICE
    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 stimulation — DEVICE
    Sham treatment mimics the active device use and the experiences from the active stimulation while minimizing active effects.

Study Details

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.

Key Dates

Start date
Jun 27, 2025
Status verified
Mar 2026
Primary completion
Oct 10, 2026
Completion
Dec 23, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active treatment
  • Sham Comparator: Sham treatment

Primary Outcome Measure

MADRS: change from baseline [ Time Frame: 10 weeks from treatment initiation. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lindus Health (virtual study site)BostonMassachusetts02111
Trial Manager
[email protected]
844-212-3083

Find similar trials in Boston, MA

By research site
Lindus Health (virtual study site)· Boston, MA

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