Deep Brain Stimulation for Parkinson's Disease

Palo Alto (17 mi)

Overseen byDoris Wang, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

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.

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

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

I am between 21 and 75 years old.

I don't have any movement issues that would stop me from having surgery.

My Parkinson's disease causes severe tremors not improved by medication.

My Parkinson's symptoms improve by 30% with medication, and I have good periods lasting at least 2 hours without severe involuntary movements.

My movement disorder is severe enough to need surgery despite medication.

I have difficulty walking or keeping my balance without medication.

Exclusion Criteria

I have had brain surgery before.

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

I do not have any medical conditions that increase my risk for surgery complications.

I have Parkinson's with mild thinking or memory problems.

Treatment Details

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.

4Treatment groups

Active Control

Group I: Open-loop deep brain stimulationActive Control1 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 stimulationActive Control1 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 movementActive Control1 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 restActive Control1 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.