Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
This study is investigating Deep Brain Stimulation (DBS) using the Medtronic Percept RC System for people with severe Bipolar I disorder who have not responded to other treatments. DBS involves a surgical procedure to place small wires (leads) in your brain, connected to a device (neurostimulator) in your chest that sends electrical signals. Researchers believe this might help rebalance brain circuits involved in bipolar depression. To join, you must be between 22 and 64 years old, have a confirmed diagnosis of Bipolar I disorder, and currently be experiencing a major depressive episode with specific symptom severity scores. The study will measure how well DBS works using scales like the Montgomery-Asberg Depression Ratings Scale (MADRS) and track any side effects. This study is currently enrolling at Baylor College of Medicine.
- Study design
- This is an interventional study with an open-label design, meaning both you and the study team will know you are receiving the active treatment. It plans to enroll 10 participants.
- What's involved
- You would undergo screening and baseline visits over approximately one month, including diagnostic assessments and medical evaluations. If eligible, you would have surgery to implant the DBS device.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be evaluated for efficacy and side effects at 20 months after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Deep Brain Stimulation of Treatment-Resistant Bipolar Depression
At a glance
Conditions
Where it's being run
4 sites across 3 statesStudy leadership
- Wayne Goodman, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
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What this trial measures
- Utilizing the Montgomery-Asberg Depression Ratings Scale (MADRS) as a measurement of Efficacy20 months
Efficacy: Primary outcome measure is a greater than or equal to 50% reduction on the Montgomery-Asberg Depression Ratings Scale (MADRS) at 9 months post-activation, compared to baseline score, which is obtained about 1 week pre-op. MADRS will evaluate Sadness, tension, Sleep, appetite, Concentration, and thoughts. This is a number scale with the higher number being a worse outcome
- Utilizing the Patient-Rated Inventory of Side Effects (PRISE) assessment for adverse events/side effects20 months
Adverse events will be elicited at each study visit using the PRISE, a standardized self-rating instrument, and confirmed by assessment of the study psychiatrist. Evaluation of manic episodes will be captured by clinical assessment to determine whether patients meet full or partial criteria for hypomanic, manic episodes, or mixed episodes. PRISE will be utilized to review Adverse Event criteria.The PRISE scale includes questions regarding subjects gastrointestinal status, heart status, skin status, nervous system status, eyes/ear status, genital/urinary status, sleep status, sexual functioning status, and "other" status with an area to specify any other concerns. This is a number scale with the higher number being a worse outcome
- Evaluation of manic episodes utilizing the Young Mania Rating Scale (YMRS)20 months
Evaluation of manic episodes will be captured by clinical assessment to determine whether patients meet full or partial criteria for hypomanic, manic episodes, or mixed episodes.This will be based on the Young Mania Rating Scale. This safety measures is administered at: screening, baseline, 1-week post-op, 2 weeks post-op (at activation visit), and then monthly for 20 months. The YMRS rating allows subjects to select from several categories to describe their level of energy. Some items include sleep, energy levels, sex drive, talkativeness, etc. This is a number scale with the higher number being a worse outcome
- Evaluation of manic episodes utilizing the Altman Self-Rating Mania Scale (ASRM)20 months
Evaluation of manic episodes will also be captured based on the self-report on the ASRM rating scale. This safety measures is administered at: screening, baseline, 1-week post-op, 2 weeks post-op (at activation visit), and then monthly for 20 months. The ASRMS rating allows subjects to select from several categories to describe their level of energy. Some items include sleep, energy levels, sex drive, talkativeness, etc. This is a number scale with the higher number being a worse outcome