Adaptive Deep Brain Stimulation to Improve Motor and Gait Functions in Parkinson's Disease

Summary

This is a single-center phase I clinical study aiming to improve gait functions in patients with Parkinson's disease (PD) by using adaptive neurostimulation to the pallidum. The investigators will use a bidirectional deep brain stimulation device with sensing and stimulation capabilities to 1) decode the physiological signatures of gait and gait adaptation by recording neural activities from the motor cortical areas and the globus pallidus during natural walking and a gait adaptation task, and 2) develop an adaptive deep brain stimulation (DBS) paradigm to selectively stimulate the pallidum during different phases of the gait cycle and measure improvements in gait parameters. This is the first exploration of network dynamics of gait in PD using chronically implanted cortical and subcortical electrodes. In addition to providing insights into a fundamental process, the proposed therapy will deliver personalized neurostimulation based on individual physiological biomarkers to enhance locomotor skills in patients with PD. Ten patients with idiopathic Parkinson's disease undergoing evaluation for DBS implantation will be enrolled in this single treatment arm study.

Conditions

• Parkinson Disease

Interventions

DEVICE

Summit RC+S

Using the RC+S pulse generator, patients receive clinically-optimized open loop DBS stimulation to the pallidum.

DEVICE

Summit RC+S

Using the RC+S pulse generator, the patients will receive closed-loop stimulation at random time points. These random stimulation times will in total equal the total amount of time of active movement.

DEVICE

Summit RC+S

Using the RC+S pulse generator, the patients will receive closed-loop stimulation during time of contralateral limb movement (e.g. left brain stimulation during right leg/arm movement).

DEVICE

Summit RC+S

Using the RC+S pulse generator, the patients will receive closed-loop stimulation during time of no movement for the contralateral limb (e.g. left brain stimulation while right leg/arm is not moving).

Sponsors & Collaborators

• Michael J. Fox Foundation for Parkinson's Research

  collaborator OTHER

• Burroughs Wellcome

  collaborator INDUSTRY

• Doris Wang, MD, PhD

  lead OTHER

Principal Investigators

• Doris Wang, MD, PhD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-15

Primary Completion

2026-09-01

Completion

2030-04-01

FDA Device

Yes

Countries

• United States

Study Locations