Using Deep Brain Stimulation to Treat Severe Bipolar Depression That Does Not Respond to Treatment A Study to Improve DBS Targeting and Monitor Mood States

What this Trial Is About

Researchers are investigating the use of Deep Brain Stimulation DBS in people with severe treatment-resistant bipolar depression TRBD. This study is conducted only at Baylor College of Medicine and aims to improve DBS targeting to better manage symptoms of TRBD by surgically implanting electrodes in specific brain areas. DBS delivers electrical currents to influence brain circuits involved in bipolar depression, but participants should understand that this is experimental and may not provide direct benefit. Risks include brain bleeding, infection, seizures, and other potential complications. Participants will undergo a detailed screening process including medical, psychiatric, and cognitive evaluations before surgery. The study involves implanting a Medtronic Percept RC DBS system with bilateral leads targeting specific brain regions. After surgery, the device will be activated and programmed over several visits. The study includes a blinded discontinuation period at 12 months to assess ongoing DBS effects. Participants will stay locally during several 24-hour monitoring periods in the NeuroBehavioral Unit to collect neural and behavioral data, using wearable sensors and mobile apps. Throughout the 20-month study, participants will attend about 23 visits for clinical assessments, questionnaires, neuropsychological and behavioral testing, and device programming. Data collection includes brain imaging, mood and mania rating scales, side effect monitoring, and continuous behavioral and neural recordings. Safety and symptom changes will be closely tracked using standardized tools like the Montgomery-Asberg Depression Rating Scale MADRS and Young Mania Rating Scale YMRS. The study aims to better understand DBS effects and improve treatment for TRBD.

Deep Brain Stimulation of Treatment-Resistant Bipolar Depression