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Deep Brain Stimulation

Deep Brain Stimulation for Parkinson's Disease

N/A

Waitlist Available

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has requested surgical intervention with deep brain stimulation for their disorder

Age 21-75

Must not have

Previous cranial surgery

Subjects who require electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS) or diathermy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to use deep brain stimulation to improve gait function in patients with Parkinson's disease. Ten patients will have electrodes implanted in their brains to record and stimulate activity in the areas involved in walking. The goal is to develop an adaptive stimulation paradigm to selectively stimulate the pallidum (a brain structure) during different phases of the gait cycle and measure improvements in gait parameters.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the implantation site, infection risk from surgery, headache or dizziness post-operation and possible hardware-related complications like lead displacement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 21 and 75 years old.

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

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

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

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

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I have difficulty walking or keeping my balance without medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had brain surgery before.

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in motor learning task completion with closed-loop compared to open-loop deep brain stimulation (DBS)

Change in motor learning task mean accuracy with closed-loop compared to open-loop deep brain stimulation (DBS).

Change in motor learning task reaction times with closed-loop compared to open-loop deep brain stimulation (DBS)

Secondary study objectives

Change in Balance

Change in Five-Times Sit to Stand Test Results

Change in Gait

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met