Study of High-Dose Transcranial Direct Current Stimulation for Treating Major Depression in Adults

What this Trial Is About

Researchers are evaluating the safety and tolerability of a higher dose of transcranial direct current stimulation tDCS, a non-invasive brain stimulation technique, in adults with major depressive disorder MDD. This study addresses the need for stronger current intensities than those previously used to engage brain targets more effectively and potentially improve treatment outcomes. The investigation includes a safety run-in phase followed by repeated sessions at a higher dose to establish whether this approach can be safely applied in this patient group. Participants receive high-dose tDCS delivered through electrodes on the scalp. The first three participants undergo a dose-escalation safety phase starting with low current intensities 2, 4, then 6 milliamps with monitoring of skin integrity before continuing. Subsequent participants receive twice-daily 20-minute sessions at 6 milliamps for five consecutive days, totaling 10 treatment sessions. Each session is followed by assessments of skin comfort, mood, and overall tolerability. During the study, participants complete evaluations at baseline, immediately after treatment, and at a 4-week follow-up. These include assessments of depressive symptoms, cognitive function, mindfulness, and safety measures such as adverse event reporting and skin checks. Researchers monitor for serious device-related side effects and track participants ability to complete all treatment sessions without discontinuation. The total participation spans treatment and follow-up over several weeks, aiming to inform future larger trials.

Accelerated High-Dose tDCS for Depression