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ENROLLING BY INVITATION
NCT03815656
NA

Closed Loop DBS Implanted RC+S Study

Sponsor: Dennis Turner, M.D.

View on ClinicalTrials.gov

Summary

This study involves patients who are already planning to have deep brain stimulation (DBS) surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals: 1. to evaluate the effectiveness of implanting DBS electrodes in the two most common locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)), instead of just one electrode, on each side of the brain; and 2. to develop an adaptive DBS system using brain signals measured from these two electrodes.

Official title: An Integrated Biomarker Approach to Personalized, Adaptive Deep Brain Stimulation in Parkinson Disease [Formerly: Scalar Closed-Loop STN/GPi DBS Based on Evoked and Spontaneous Potentials (Permanently Implanted Medtronic RC+S Studies)]

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2019-07-10

Completion Date

2027-01

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

DEVICE

STN alone

DBS stimulation of STN alone

DEVICE

GPi alone

DBS stimulation of GPi alone

DEVICE

STN + GPi

cooperative DBS stimulation of STN and GPi sites

DEVICE

Closed-loop stimulation

adaptive DBS stimulation of STN and/or GPi sites

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States