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NCT06599099 · ClinicalTrials.gov registry record · NA
Deep Brain Stimulation of Treatment-Resistant Bipolar Depression
A NA study of Bipolar Depression, sponsored by Wayne Goodman MD.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 4
- Study locations
NCT06599099 is a NA study of Bipolar Depression that is actively recruiting participants, run by Wayne Goodman MD. The registered enrollment target is 10 participants, below the 216-participant average among 29 other Bipolar Depression trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT06599099, a NA study of Bipolar Depression, is actively recruiting participants, sponsored by Wayne Goodman MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 4
- Study locations
Study Summary
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 deciding to participate or not. Some of the risks are from surgery, the DBS device and programming, the tests involved, and potential loss of confidentiality, as well as other unknown risks. Some of the more serious risks involved in this study and the percentage that they occur: 1. Bleeding inside the Brain (1 to 2 percent). 2. Infection from the procedures (3 percent) 3. Seizure caused from the procedures (1.2 percent) However, the benefit of this study is that it may help relieve or decrease TR
Conditions Studied
Interventions
- DEVICE Medtronic Percept RC System
- BEHAVIORAL One Month Blinded Discontinuation Period
Study Locations (4)
Texas
- Baylor College of Medicine - Houston
- Rice University - Houston
Massachusetts
- Massachusetts General Hospital - Boston
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2030-05-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06599099
The ClinicalTrials.gov registry entry for NCT06599099 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 216-participant average among 29 other Bipolar Depression trials with a reported enrollment target (95% lower). The listed sponsor is Wayne Goodman MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Depression appearing as the primary indexed condition, and to 2 interventions - of which Medtronic Percept RC System is the first listed.
NCT06599099 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Texas, Massachusetts, Washington.
Frequently Asked Questions
What is clinical trial NCT06599099 about?
NCT06599099 is a clinical study titled "Deep Brain Stimulation of Treatment-Resistant Bipolar Depression". 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) s...
What is the current status of trial NCT06599099?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2025-01-01. Estimated completion is 2030-05-30.
What conditions does trial NCT06599099 study?
This clinical trial studies the following conditions: Bipolar Depression.
What interventions are being tested in trial NCT06599099?
The interventions under investigation include: Medtronic Percept RC System (DEVICE), One Month Blinded Discontinuation Period (BEHAVIORAL).
Who is sponsoring clinical trial NCT06599099?
This trial is sponsored by Wayne Goodman MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06599099 being conducted?
This trial has 4 study locations across Massachusetts, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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