Home-based Brain Stimulation Using tDCS for Adults with Bipolar Depression A Randomized, Placebo-Controlled Study

What this Trial Is About

Bipolar depression is a persistent and disabling condition where many people continue to have depressive symptoms despite standard treatments. Researchers are evaluating whether a home-based transcranial direct current stimulation tDCS device is effective and safe in reducing symptoms of bipolar depression compared to a placebo sham treatment. The study also explores how acceptable the treatment is to participants and how well they can use the device at home. Participants will be randomly assigned to use either an active tDCS device or a sham placebo device at home over a 10-week treatment period. The device used is the Flow FL-100 tDCS headset, which delivers a low-intensity electrical current to the brains dorsolateral prefrontal cortex. This is a portable device that participants will self-administer, with neither they nor the researchers knowing which treatment they receive during the trial. During the study, participants will complete scheduled assessments including clinician interviews and self-reported questionnaires on mood and well-being. Device usage and adherence will be electronically monitored. Participants will be followed for 6 months after treatment to assess effects on depressive and anxiety symptoms, as well as quality of life. Safety and any side effects such as mild tingling or skin irritation will be closely monitored throughout the study, which primarily takes place remotely from participants homes.

A Study of Home-use Brain Stimulation to Treat Bipolar Depression