Evaluating Deep Transcranial Magnetic Stimulation as a Treatment for Bipolar Depression A Randomized, Double-Blind Study on Effects and Cognitive Benefits in Adults

What this Trial Is About

Researchers are studying the use of deep transcranial magnetic stimulation dTMS as an additional treatment for people with bipolar depression. The study aims to assess whether dTMS can improve depressive symptoms and cognitive function in these patients. This is a randomized, double-blind, sham-controlled trial involving 100 participants to evaluate the effects and tolerability of dTMS. Participants are randomly assigned to receive either active dTMS or sham placebo stimulation. Both groups undergo daily 20-minute sessions for five days each week over four weeks, except weekends. The active treatment uses the H1 coil delivering 55 trains of 18 Hz stimulation at 120% motor threshold, totaling 1980 pulses per session. The sham group follows the same schedule but with a sham coil that mimics the procedure without active stimulation. Throughout the study, participants have assessments at the start, after 2 weeks, 4 weeks, and 8 weeks. These include depression and anxiety rating scales, cognitive tests, and blood samples to measure brain-derived neurotrophic factor levels. Researchers will monitor symptom changes, cognitive function, and any side effects. The study concludes in February 2026, with ongoing evaluation of treatment response and safety.

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression