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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
Ability of patient and/or caregivers to recharge the system evaluated by all clinicians and study personnel
Patient has requested surgical intervention with deep brain stimulation for their disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 or my caregiver can recharge the medical device as needed.
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I have chosen to undergo deep brain stimulation surgery for my condition.
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My oral medication for movement issues hasn't worked well, as confirmed by a specialist.
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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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I have been diagnosed with Parkinson's disease for over 3 years.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in Balance
Change in Five-Times Sit to Stand Test Results
Change in Gait
+5 more

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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,461 Total Patients Enrolled
Doris Wang, MD, PhDLead Sponsor
Michael J. Fox Foundation for Parkinson's ResearchOTHER
112 Previous Clinical Trials
535,146 Total Patients Enrolled

Media Library

Summit RC+S (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04675398 — N/A
Parkinson's Disease Research Study Groups: Open-loop deep brain stimulation, Randomized deep brain stimulation, Deep brain stimulation during contralateral limb movement, Deep brain stimulation during contralateral limb rest
Parkinson's Disease Clinical Trial 2023: Summit RC+S Highlights & Side Effects. Trial Name: NCT04675398 — N/A
Summit RC+S (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04675398 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for potential participants in this experiment?

"As per clinicaltrials.gov, this trial is no longer engaging with potential participants; the initial post-date was June 15th 2021 and it last updated on October 4th 2022. However, there are still plenty of other medical studies that need volunteers at present – 483 to be exact!"

Answered by AI

Who is eligible to participate in this research endeavor?

"This investigation is looking for 10 individuals with Parkinson's disease aged between 18 and 75. Necessary criteria includes: movement disorder issues that necessitate the surgical implantation of deep brain stimulators, patient requesting surgery to address their condition, no motion-related abnormalities hinting at an alternative diagnosis or contraindicating medical procedure, capacity to adhere to study follow-up visits for neurological recording, testing of adaptive stimulation, and clinical evaluation., age range 21 -75 years old , inadequate relief from conventional medication as judged by a neurologist specialising in motor disorders , absence of significant cognitive impairment (score of 21 or higher on Montreal Cognitive Assessment"

Answered by AI

Is enrollment open to those aged 70 or above for this trial?

"Participants of this clinical trial must be over 18 years old, yet younger than 75."

Answered by AI

What aims are the researchers hoping to achieve from this investigation?

"According to Burroughs Wellcome, the primary outcome that will be evaluated in this trial across a two year span is motor learning task mean accuracy with closed-loop compared to open-loop deep brain stimulation (DBS). Additionally, investigators plan on assessing other variables including stride length as measured by Rover and Xsens devices in metres, five times sit to stand test results which are scored based off speed of transition from sitting to standing position and back again, along with MDS-UPDRS III scores ranging from 0 - 72 points."

Answered by AI
~3 spots leftby Apr 2025