← Back to Search

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: Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment
Dystonia: Patient has requested surgical intervention with deep brain stimulation for their disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I can attend all required study visits for my dystonia treatment.
Select...
I have requested surgery for my dystonia.
Select...
I have Parkinson's and am considering deep brain stimulation surgery.
Select...
My MRI does not show any issues that would rule out surgery for Parkinson's.
Select...
My brain scans do not show any issues that would prevent surgery or suggest a different diagnosis than dystonia.
Select...
I have been on stable doses of my dystonia medication for at least 30 days.
Select...
My Parkinson's symptoms are severe enough to need surgery despite medication.
Select...
My thinking and memory skills are good (MoCA score ≥ 20).
Select...
I have signed the consent form for my dystonia treatment.
Select...
I am between 21 and 75 years old and have dystonia.
Select...
I have dystonia in my face and neck, and botulinum toxin treatments haven't worked well.
Select...
I have signed a consent form for Parkinson's Disease treatment.
Select...
I have Parkinson's and my current medication isn't working well, as confirmed by a specialist.
Select...
My Parkinson's symptoms improve by 30% with medication, and I have at least 2 hours a day of good symptom control.
Select...
My movement disorder is severe enough to need surgery despite medication.
Select...
I have Parkinson's with severe, treatment-resistant tremors despite medication.
Select...
I have been diagnosed with a type of dystonia affecting my neck, head, or entire body.
Select...
I have been diagnosed with Parkinson's Disease for over 4 years.
Select...
I am between 21 and 75 years old and have Parkinson's Disease.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Parkinson's disease patients GP TargetExperimental Treatment3 Interventions
Parkinson's disease patients implanted in Globus Pallidus
Group II: Parkinson's Disease STN TargetExperimental Treatment3 Interventions
Parkinson's disease patients implanted in STN
Group III: Dystonia patientsExperimental Treatment2 Interventions
Isolated dystonia patients

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,773 Total Patients Enrolled
7 Trials studying Dystonia
326 Patients Enrolled for Dystonia
Philip A Starr, MD/PhDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Summit RC+S (Neural Interface) Clinical Trial Eligibility Overview. Trial Name: NCT03582891 — N/A
Dystonia Research Study Groups: Parkinson's disease patients GP Target, Dystonia patients, Parkinson's Disease STN Target
Dystonia Clinical Trial 2023: Summit RC+S Highlights & Side Effects. Trial Name: NCT03582891 — N/A
Summit RC+S (Neural Interface) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03582891 — N/A

Frequently Asked Questions

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

Who meets the eligibility criteria to take part in this clinical experiment?

"Clinicians are looking for 25 adults aged 21 and 75 that suffer from dystonia. In order to be eligible, patients must have movement disorder symptoms severe enough to warrant surgical implantation of deep brain stimulators as per standard clinical criteria, no MR abnormalities contraindicating surgery, the capacity to comply with study protocols including follow-up visits and brain recording tests, absence of cognitive impairment (scoring 20+ on MoCA), signed informed consent if PD is present it should have a minimum duration of 4 years with stable medication doses 30 days prior to baseline assessment."

Answered by AI

Does this research include participants younger than 40 years of age?

"As outlined in the trial's inclusion criteria, participants must be between 21 and 75 years of age."

Answered by AI

How many participants are involved in this research endeavor?

"Correct. Records on clinicaltrials.gov verify that this medical trial, first posted October 1st 2018, is actively looking for participants. A total of 25 patients must be recruited from one location."

Answered by AI

Is this experiment actively accepting participants?

"Data hosted on clinicaltrials.gov denotes that this medical research is actively recruiting individuals, with the study's commencement listed as October 1st 2018 and its most recent update being issued on September 16th 2022."

Answered by AI

What are the fundamental goals of this experiment?

"This study is designed to measure the efficacy of open and closed-loop stimulation during chronic adaptive deep brain simulation (DBS) testing at home, with the Toronto Western Spasmodic Torticollis Rating Scale being used for dystonia patients. Further assessments include Hoehn and Yahr Staging in medication 'on' state when using adaptive compared to standard open loop stimulation, as well as Patient's Global Impression of Change scores and resting state EEG recordings which serve as a surrogate marker of alertness."

Answered by AI
~5 spots leftby Jul 2025