Randomized Study of Temporal Interference Stimulation for Treating Bipolar Depression with Safety and Brain Imaging Analysis

What this Trial Is About

Researchers are studying the use of temporal interference stimulation, a non-invasive brain stimulation method, to improve symptoms of bipolar depression. The study also aims to explore related brain activity changes using magnetic resonance imaging and electroencephalogram, which may help develop new treatment approaches and objective ways to predict treatment effects in bipolar disorder. Participants will be randomly assigned to receive either active temporal interference stimulation or a sham version that mimics the sensation without real stimulation. The treatment involves delivering high-frequency electrical fields to the brain. The study uses a double-blind design, meaning neither participants nor researchers know who receives real or sham stimulation during the treatment. During the study, participants will be assessed using several depression and anxiety rating scales, including the Montgomery-Asberg Depression Rating Scale at baseline, day 5, and multiple follow-ups up to 4 weeks after treatment. Other evaluations include mania, pleasure experience, depressive symptoms, anxiety levels, and cognitive function tests. Safety and efficacy will be closely monitored throughout the study period, which runs until December 2026.

Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression