Safety And Efficacy of Remotely Supervised Home-Based tDCS Treatment Of Major Depressive Disorder
Sooma Medical Inc
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.
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.
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
In short, Inclusion Criteria: * 22 - 70 years of age * Diagnosis of Unipolar MDD (DSM-V) * PHQ-9 score of ≥12 AND MADRS score of ≥ 20 at baseline * Antidepressant medication ongoing * If in psychotherapy, have maintained stable psychotherapy * Have access to a smartphone or other device running Android 7.0+ or iPhone Operating System (iOS) 13+ * Be under the care of a psychiatrist or a primary care physician * Allow communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two year…
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.
Location
- Lindus Health (virtual study site)Boston, Massachusetts