10
Participants
Start Date
January 1, 2025
Primary Completion Date
May 30, 2029
Study Completion Date
May 30, 2030
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"
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.
RECRUITING
Baylor College of Medicine, Houston
ACTIVE_NOT_RECRUITING
Rice University, Houston
ACTIVE_NOT_RECRUITING
University of Washington, Seattle
ACTIVE_NOT_RECRUITING
Massachusetts General Hospital, Boston
University of Washington
OTHER
William Marsh Rice University
OTHER
Massachusetts General Hospital
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Wayne Goodman MD
OTHER