Study of Accelerated Intermittent Theta-burst Stimulation 1W-AiTBS to Treat Depression

What this Trial Is About

Researchers are evaluating the effectiveness of an accelerated intermittent theta-burst stimulation 1W-AiTBS protocol in treating depression. This therapy is a type of repetitive transcranial magnetic stimulation rTMS applied to the brains dorsolateral prefrontal cortex. The study aims to observe how well this accelerated treatment works in everyday clinical practice, enrolling up to 150 patients over 1.5 years, with a target of at least 36 participants. The treatment involves magnetic pulses delivered with a specialized device targeting a specific brain area. Each session lasts about 3 minutes and 20 seconds, with 600 pulses per session. Patients may receive up to 8 sessions per day, spaced by more than 15 minutes, totaling 30 treatments over approximately 10 weekdays. The device coil is positioned carefully using a standardized method to ensure correct targeting. Participants will complete self-rating questionnaires at screening, before and after the treatment period, and at 6 weeks, 12 weeks, and 6 months after starting treatment. Researchers will monitor changes in depression scores and side effects over time. The main outcome measured is the difference in depression rating scale MADRS-S scores from baseline to six weeks after the first treatment session. Safety and tolerability data will also be collected throughout the study.

Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)