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Neural Interface

Deep Brain Stimulation for Parkinson's Disease

N/A

Waitlist Available

Led By Philip A Starr, MD/PhD

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

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

Parkinson's Disease: Patient has requested surgical intervention with deep brain stimulation for their disorder

Must not have

Parkinson's Disease: Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or 'while unobserved', symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as 'false' signs, multiple somatizations, or obvious psychiatric disturbance

Parkinson's Disease: Drug or alcohol abuse

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is to study a new way to help those with Parkinson's disease or dystonia using a deep brain stimulator that is controlled by feedback from the brain.

Who is the study for?

This trial is for adults aged 21-75 with Parkinson's Disease or Dystonia who need surgical intervention despite medication. Participants must be able to consent, follow the study schedule, and have no significant cognitive impairment (MoCA score ≥20). Exclusions include drug/alcohol abuse, certain cognitive impairments in PD patients, psychogenic movement disorders, pregnancy, implanted devices like pacemakers or neurostimulators, coagulopathy or other surgery risks.

What is being tested?

The study tests a neural interface device called Medtronic Summit RC+S in people with Parkinson's Disease and Dystonia. It explores how brain activity relates to motor symptoms by comparing closed-loop stimulation (automatic adjustment) versus open-loop stimulation (constant level) over an eight-week period.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, infection risk from surgery, possible changes in mood or behavior due to brain stimulation adjustments. Since it's a pilot trial focusing on device safety and effectiveness rather than medications' side effects are not fully known.

Eligibility Criteria

Inclusion Criteria

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

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I have requested surgery for my dystonia.

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I have Parkinson's and am considering deep brain stimulation surgery.

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My MRI does not show any issues that would rule out surgery for Parkinson's.

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My brain scans do not show any issues that would prevent surgery or suggest a different diagnosis than dystonia.

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My Parkinson's symptoms are severe enough to need surgery despite medication.

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My thinking and memory skills are good (MoCA score ≥ 20).

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I have dystonia in my face and neck, and botulinum toxin treatments haven't worked well.

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My Parkinson's symptoms improve by 30% with medication, and I have at least 2 hours a day of good symptom control.

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

Exclusion Criteria

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

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My Parkinson's symptoms improve when distracted or not observed, and vary widely.

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I do not abuse drugs or alcohol.

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I have Parkinson's but no major health issues that increase surgery risks.

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I have Parkinson's and need specific brain stimulation treatments.

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I have Parkinson's and have had brain surgery before.

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

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I have had brain surgery for my dystonia.

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I need ECT, rTMS, or diathermy for my dystonia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 4 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

Duration of 'on' stimulation time without dyskinesia from motor diaries in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)

Karolinska Sleepiness Scale

Positive and Negative Affect Schedule (PANAS-SF)

+3 more

Secondary study objectives

Hoehn and Yahr Staging in the medication 'on' state in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)

Patient Global Impression of Change (Dystonia Patients)

Patient's Global Impression of Change (PGIC) in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)

+6 more