Sooma Medical Inc
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.
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.
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…
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 treatment mimics the active device use and the experiences from the active stimulation while minimizing active effects.
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