Comparing Home and Clinic-Based tDCS Treatments for Major Depression Randomized Study of Accelerated and Conventional Home tDCS Protocols

What this Trial Is About

Researchers are evaluating the safety and effectiveness of home-based transcranial direct current stimulation tDCS for treating major depression. This randomized controlled trial compares home tDCS with tDCS delivered in a healthcare center and explores the impact of an accelerated home tDCS schedule. The main measure of success is the change in depression severity at the end of treatment, assessed by the Montgomery-sberg Depression Rating Scale MADRS. The study has three treatment groups an accelerated home tDCS protocol applied over 3 weeks with 42 sessions, a conventional home tDCS protocol over 9 weeks with 42 sessions, and conventional ambulatory tDCS in a medical facility over 9 weeks with 42 sessions. Each session uses a weak direct current of 2 mA applied to specific brain areas for 20 minutes. The accelerated home group receives multiple daily sessions initially, reducing frequency over three weeks, while the other groups have daily sessions Monday to Friday for nine weeks. Participants will be monitored closely during the study through regular assessments including depression rating scales at several time points, such as after 2 weeks, at the end of treatment, and during follow-up months later. Safety and treatment adherence will be supervised, and secondary measures include anxiety and global impression scores. The total participation period varies by group but includes treatment and follow-up visits extending up to 21 weeks. This study is sponsored by Ionclinics & Deionic SL.

Home tDCS for the Treatment of Major Depression.