Home-Based Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression Safety and Feasibility Study with Remote Supervision

What this Trial Is About

Researchers are evaluating the effectiveness, safety, tolerability, and feasibility of at-home transcranial direct current stimulation tDCS as a treatment for depression, especially for patients who have not responded well to traditional therapies. This study focuses on treatment-resistant depression and major depressive disorder, aiming to understand changes in mood, brain activity, and clinical outcomes through this novel approach. The study is open-label and involves direct remote supervision during treatment. Treatment consists of self-administered tDCS sessions at home using the Soterix Medical mini-CT device. Participants will receive five tDCS sessions daily on weekdays over a two-week period. Each session lasts 20 minutes with approximately 20-minute breaks between sessions, totaling three hours of stimulation per day. The device delivers low-intensity electrical stimulation at 2 mA with gradual ramp-up and ramp-down phases. Additionally, there will be four in-person appointments required in San Diego, California. Participants will be monitored through pre- and post-treatment neurophysiological biomarker sessions, including measurements such as TMS-EMG and resting-state EEG. Researchers will assess feasibility aspects like recruitment, retention, adherence, and safety over a 12-week period following treatment. The study will also track changes in depressive symptoms and brain activity to inform future research. Participants can expect clinical assessments, remote supervision, and scheduled in-person visits during their involvement, which lasts from baseline until 12 weeks post-treatment.

Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study