Condition: Bipolar Depression · Sponsor: Wayne Goodman MD
This study is only enrolling at Baylor College of Medicine. The other research locations listed serve to support data analysis only. This research study is to investigate the use of technology called Deep Brain Stimulation (DBS) to potentially improve Treatment-Resistant Bipolar Depression (TRBD) symptoms in patients with severe cases. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed DBS may restore balance to dysfunctional brain circuitry implicated in TRBD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for TRBD treatment. Its important for participants to understand that this is an investigational study where there could be a lack of effectiveness in improving TRBD symptoms. There may be no directly benefit from taking part in this study. This study is expected to last 20 months and involves 3 main steps. 1. Medical, psychiatric, and cognitive evaluations. 2. Implantation of a brain stimulation system. 3. Follow up after implantation of device, including programming, recording, and psychiatric testing. There are risks and benefits to this study which need to be considered when decid…
This description comes directly from the study's public registry record.
Michelle Avendano · 713-798-4729 · mavendan@bcm.edu
Luke Jumper · 713-798-4113 · jumper@bcm.edu
Always discuss trial participation with your own doctor first.
| Massachusetts General Hospital | Boston, Massachusetts, United States | Active Not Recruiting |
| Baylor College of Medicine | Houston, Texas, United States | Recruiting |
| Rice University | Houston, Texas, United States | Active Not Recruiting |
| University of Washington | Seattle, Washington, United States | Active Not Recruiting |
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Source record: clinicaltrials.gov/study/NCT06599099