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Deep Brain Stimulation for Movement Disorders
N/A
Recruiting
Led By Debra J Ehrlich, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 years of age or older
Have a clinical diagnosis of idiopathic PD, primary dystonia, or ET based on specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a treatment for people with movement disorders using deep brain stimulation.
Who is the study for?
This trial is for adults over 18 with Parkinson's Disease (PD), essential tremor (ET), or certain dystonias who've had a good response to dopaminergic meds for PD. It's not suitable for those with significant medical risks, secondary movement disorders, dementia, pregnancy, psychiatric issues, or an inability to undergo MRI scans.Check my eligibility
What is being tested?
The study tests Deep Brain Stimulation (DBS) therapy in managing movement disorders. Participants will have DBS surgery followed by regular check-ups where the neurostimulator settings are adjusted based on their condition and responses assessed through various physical and cognitive tests.See study design
What are the potential side effects?
Potential side effects of DBS may include headache, infection at the site of surgery or device implantation area, speech problems, balance issues, mood changes and possible complications from brain surgery like bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with Parkinson's, primary dystonia, or essential tremor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Data collection
To maintain a cohort of patients treated with DBS who can participate in other NIH protocols addressing the efficacy of functional surgery and the relevant physiology
To provide DBS therapy and follow-up management
Secondary outcome measures
To access other clinical outcome measures related to response to therapy
To collect physiology data correlated with motor and cognitive function in these
To correlate radiographic data related to DBS electrode position with clinical changes
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-armExperimental Treatment1 Intervention
Therapy
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,340 Previous Clinical Trials
649,064 Total Patients Enrolled
Debra J Ehrlich, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
7 Previous Clinical Trials
12,709 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considering or already have a deep brain stimulation device for my movement disorder.I have serious health conditions that could make treatment risky.I have unusual or secondary movement disorders like shaking or stiffness.I am 18 years old or older.I have been diagnosed with Parkinson's, primary dystonia, or essential tremor.I've responded well to dopamine medication or not improved with maximum treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Single-arm
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the estimated number of participants in this clinical research?
"Affirmative, the clinical trial is still actively recruiting participants. The research was initially posted on April 2nd 2014 and has been recently updated as of November 16th 2022. 300 prospective patients need to be enlisted from two separate locations for this medical experiment."
Answered by AI
Is recruitment open for this experiment?
"The clinical trial is still accepting applicants, as reported on the clinicaltrials.gov website. This scientific experiment was first posted on April 2nd 2014 and last modified November 16th 2022."
Answered by AI
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