Deep Brain Stimulation of Treatment-Resistant Bipolar Depression

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

May 30, 2029

Study Completion Date

May 30, 2030

Conditions
Bipolar Depression
Interventions
DEVICE

Medtronic Percept RC System

"Medtronic Percept RC System includes:~Percept RC neurostimulator SenSight Directional Lead Kit (with and without marker; 33cm and 42cm lengths) SenSight Directional Lead Kit (with and without marker; 33cm and 42cm lengths) SenSight Extension Kit (with and without marker; 40cm, 60cm, and 95cm lengths) Percept DBS Handset and Communicator Kit (patient programmer) SenSight Extension Tunneler Kit SenSight Burr Hole Device Kit Clinician Programmer Application (application runs on Model CT900 Tablet) Percept RC Recharger Kit Recharge Application Software Clinician Communicator/Telemetry Module"

BEHAVIORAL

One Month Blinded Discontinuation Period

The investigators will use blinded discontinuation at 12 months rather than sham control to establish evidence that response is dependent on ongoing DBS. The open-label design allows for personalized optimization of programming settings - a strength of this design as related to our study goals. Although one of the goals of this study is to use neural recordings to inform programming, currently, unblinded programming is needed to maximize response and minimize side effects. Adverse events will be elicited at each study visit using a standardized instrument, the Patient-Rated Inventory of Side Effects (PRISE). In addition to monitoring for adverse events related to surgery and stimulation, the investigators will track quality of life (QOLS), global functioning (SDS), and necessary adjustments of medications. The behavioral changes of the subject based on these scales will provide insight to the intervention levels provided from discontinuing the therapy from the device.

Trial Locations (4)

77030

RECRUITING

Baylor College of Medicine, Houston

ACTIVE_NOT_RECRUITING

Rice University, Houston

98195

ACTIVE_NOT_RECRUITING

University of Washington, Seattle

02114

ACTIVE_NOT_RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

University of Washington

OTHER

collaborator

William Marsh Rice University

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Wayne Goodman MD

OTHER