Deep Brain Stimulation for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen by Doris Wang, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Doris Wang, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for Parkinson's Disease patients aged 21-75 with motor symptoms for over 3 years, experiencing gait impairments despite medication. They must be able to consent, travel to the study site, recharge the device, and have a significant improvement in their condition on medication. Excluded are those with psychogenic disorders, pregnant women, substance abuse issues, cognitive impairments or allergies to device materials.

Inclusion Criteria

Ability to give informed consent for the study

I or my caregiver can recharge the medical device as needed.

I have chosen to undergo deep brain stimulation surgery for my condition.

Exclusion Criteria

I have had brain surgery before.

I need treatments like ECT, rTMS, or diathermy for my condition.

You have a history of using drugs or alcohol in a harmful way.

Treatment Details

Interventions

• Summit RC+S (Deep Brain Stimulation)

Trial Overview The Summit RC+S deep brain stimulation device is being tested on Parkinson's patients to improve walking functions by stimulating the pallidum during different phases of gait. This phase I study records neural activities and aims to personalize neurostimulation based on physiological biomarkers.

Participant Groups

Group I: Open-loop deep brain stimulation Active Control 1 Intervention

Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation.

Group II: Randomized deep brain stimulation Active Control 1 Intervention

Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving closed-loop stimulation at random time points.

Group III: Deep brain stimulation during contralateral limb movement Active Control 1 Intervention

Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving closed-loop stimulation during time of contralateral limb movement.

Group IV: Deep brain stimulation during contralateral limb rest Active Control 1 Intervention

Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving closed-loop stimulation during time of no movement for contralateral limb.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

Doris Wang, MD, PhD

Lead Sponsor

Trials

2

Recruited

30+

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Trials

117

Recruited

537,000+

Deborah W. Brooks

Michael J. Fox Foundation for Parkinson's Research

Chief Executive Officer since 2021

AB in Economics from the College of William and Mary, MBA from the Tuck School at Dartmouth College, MS in Marital and Family Therapy from Northwestern University

Mark Frasier

Michael J. Fox Foundation for Parkinson's Research

Chief Medical Officer since 2006

PhD in Pharmacology from Loyola University Chicago

Burroughs Wellcome

Industry Sponsor

Trials

8

Recruited

2,800+