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ACTIVE NOT RECRUITING
NCT03582891
NA

The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson's disease and isolated dystonia patients will be implanted unilaterally or bilaterally with a totally internalized bidirectional neural interface, Medtronic Summit RC+S. This study includes three populations: ten PD patients undergoing deep brain stimulation in the subthalamic nucleus (STN), ten PD patients with a globus pallidus (GPi) target and five dystonia patients. All groups will test a variety of strategies for feedback-controlled deep brain stimulation, and all patients will undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days.

Official title: Closed Loop Deep Brain Stimulation in Parkinson's Disease and Dystonia (Activa RC+S)

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2018-10-01

Completion Date

2028-03

Last Updated

2025-04-13

Healthy Volunteers

No

Interventions

DEVICE

Summit RC+S for Motor

Using the RC+S pulse generator, investigators will measure cortical biomarkers of hyper and hypokinesia in Parkinson's and dystonia patients to develop an adaptive algorithm which adjusts the level of deep brain stimulation needed based upon the patient's physiology.

DIAGNOSTIC_TEST

8-week pilot trial of Closed-loop vs. Open-loop Stimulation

These patients will participate in an 8 week clinical trial of open loop versus adaptive mode (4 weeks for each mode (interleaved), with the order counterbalanced across subjects ).

DEVICE

Summit RC+S for Sleep

Using the RC+S pulse generator, investigators will measure cortical biomarkers of sleep stages in Parkinson's patients to develop an adaptive algorithm which adjusts the level of deep brain stimulation needed based upon the patient's physiology.

Locations (1)

University of California at San Francisco

San Francisco, California, United States