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This open-label pilot study tested a higher-intensity transcranial direct current stimulation protocol (6 mA, twice daily for five days) in 20 patients with major depressive disorder, using novel equipment designed to improve skin tolerance. All participants completed the treatment protocol with 100% adherence and minimal adverse effects beyond temporary skin reactions, though two Black participants experienced persistent hyperpigmentation. Depression scores improved significantly, with 50% of participants showing clinical response and 45% achieving remission by the end of treatment, with benefits maintained at one-month follow-up.
Why it matters
This study suggests that higher-intensity tDCS protocols may be safely administered and could potentially provide faster or more effective depression treatment than the currently FDA-approved 2 mA protocol. However, the findings require confirmation in placebo-controlled trials, and the hyperpigmentation observed in darker-skinned participants warrants careful monitoring in diverse populations.
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⚠️ Preprint – Noch nicht peer-reviewed
Dieser Artikel wurde noch nicht von unabhängigen Experten begutachtet. Die Ergebnisse sind vorläufig und sollten mit Vorsicht interpretiert werden.
Home-based 2 mA transcranial direct current stimulation (tDCS) was recently approved by the US Food and Drug Administration for depression, but tDCS amplitude has been limited largely by skin tolerance, and higher-intensity, accelerated dosing may be more efficacious or faster-acting. Using a novel high-capacity tDCS (HC-tDCS) stimulator and hydrogel electrodes, we evaluated the safety, tolerability and feasibility of accelerated HC-tDCS (20-minute bifrontal 6 mA sessions, twice daily for five days) in 20 patients with major depressive disorder. A Safety Review Committee reviewed data from the first three participants, who completed a within-day escalation to 6 mA, before the remaining 17 were enrolled. Retention and adherence were 100% (203 of 203 sessions), and 19/20 tolerated the full 6 mA amplitude without dose reduction. There were no serious adverse events. The most common symptoms were fatigue (49% of sessions), burning (46%) and tingling (43%) at the electrode, and difficulty concentrating (40%). Electrode-site erythema occurred in all participants, with no severe reaction or skin breakdown. At 1 week, 7 of 20 reported a residual skin change, mostly peeling or redness, none painful; at 1 month, hyperpigmentation at the electrode site persisted in 2 participants, both Black. At the end of the five-day course, PHQ-9 scores decreased from 15.8 to 7.2 (Hedges g = 1.62); 50% of participants responded, 45% remitted, and improvement was maintained at 1-month follow-up. Accelerated HC-tDCS was feasible, well tolerated, and warrants a sham-controlled trial.