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Deep Brain Stimulation for Parkinson's Disease
N/A
Waitlist Available
Led By Warren M Grill, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Parkinson's Disease (PD), Essential Tremor (ET) or Multiple Sclerosis (MS)
Neurologically stable
Must not have
Inability to execute the motor tasks during the study
Inability to tolerate withholding anti-parkinsonian and/or anti-tremor medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing different types of deep brain stimulation to see which is most effective in treating Parkinson's, essential tremor, and multiple sclerosis. The results will help design more effective stimulation patterns and aid in understanding how DBS works.
Who is the study for?
This trial is for individuals with Parkinson's Disease, Essential Tremor, or Multiple Sclerosis who are neurologically stable and scheduled for Deep Brain Stimulation surgery. Participants must understand the study and consent form. Those unable to perform motor tasks or tolerate medication withdrawal, or with ineffective DBS are excluded.
What is being tested?
The study measures how non-regular deep brain stimulation patterns affect motor symptoms and neural activity in patients with PD, ET, or MS. The goal is to develop more effective DBS treatments by understanding its mechanisms better.
What are the potential side effects?
While not explicitly listed here, potential side effects of DBS can include headache, seizure, confusion, difficulty concentrating, mood changes and hardware complications like infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Parkinson's, Essential Tremor, or Multiple Sclerosis.
Select...
My neurological condition is stable.
Select...
I am scheduled for DBS surgery or to have my DBS battery replaced.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot perform certain physical tasks required in the study.
Select...
I cannot stop taking my Parkinson's or tremor medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fingers
Neural Activity
Tremor Accelerometry
Secondary study objectives
Electrode Location
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Therapeutic Stimulation PatternsExperimental Treatment1 Intervention
This group will receive temporal patterns of stimulation that are designed to suppress oscillatory neural activity at theta- or beta-frequencies. These patterns are hypothesized to alleviate motor symptoms.
Group II: Symptogenic Stimulation PatternsExperimental Treatment1 Intervention
This group will receive symptogenic patterns of stimulation that are designed to exacerbate oscillatory neural activity at theta- or beta-frequencies. These patterns are hypothesized to exacerbate motor symptoms.
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationIndustry Sponsor
744 Previous Clinical Trials
857,643 Total Patients Enrolled
Duke UniversityLead Sponsor
2,454 Previous Clinical Trials
2,971,524 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,377 Previous Clinical Trials
651,657 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Parkinson's, Essential Tremor, or Multiple Sclerosis.My neurological condition is stable.Deep brain stimulation (DBS) is not working to improve symptoms.I cannot perform certain physical tasks required in the study.I cannot stop taking my Parkinson's or tremor medications.I am scheduled for DBS surgery or to have my DBS battery replaced.
Research Study Groups:
This trial has the following groups:- Group 1: Symptogenic Stimulation Patterns
- Group 2: Therapeutic Stimulation Patterns
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT02553525 — N/A
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