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Deep Brain Stimulation for Parkinson's Disease
N/A
Recruiting
Led By Nicole Bentley, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eligible for DBS surgery based on multi-disciplinary consensus review
Have a diagnosis of Parkinson's disease or Essential Tremor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial is investigating the brain activity associated with non-motor symptoms of movement disorders like Parkinson's and essential tremor. They're using recordings from deep brain stimulation surgery to do this.
Who is the study for?
This trial is for adults with Parkinson's disease or Essential Tremor who are eligible for deep brain stimulation (DBS) surgery. Candidates must be willing to participate in the study activities and have been reviewed by a multi-disciplinary team. People cannot join if they can't fully consent, aren't surgical candidates due to other health issues or pregnancy, haven't tried medical management adequately, or DBS isn't indicated for their condition.Check my eligibility
What is being tested?
The study investigates brain activity related to non-motor symptoms like depression and cognitive impairment in movement disorders. It involves additional brain surface recordings during routine DBS surgery to understand these symptoms better.See study design
What are the potential side effects?
Since this trial focuses on observation rather than medication, side effects are not the primary concern; however, typical risks associated with DBS surgery may apply.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
A team of doctors agrees I am a candidate for DBS surgery.
Select...
I have been diagnosed with Parkinson's disease or Essential Tremor.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accuracy via Simon Task (% correct)
Dementia Rating Scale Score 0-144 points (Higher score represents better symptoms)
Response times via Simon Task (sec)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Parkinson's Disease Patients receiving DBS electrodes
Group II: ControlActive Control1 Intervention
Control subjects will be non-Parkinson's Disease patients with essential tremor
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,274 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,584 Previous Clinical Trials
2,279,984 Total Patients Enrolled
Nicole Bentley, MD5.014 ReviewsPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
1 Previous Clinical Trials
90 Total Patients Enrolled
5Patient Review
Dr. George has always been a consummate professional in our interactions.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- A team of doctors agrees I am a candidate for DBS surgery.I have been diagnosed with Parkinson's disease or Essential Tremor.I cannot take part in study activities.I cannot have surgery because of other health issues or because I am pregnant.Deep Brain Stimulation surgery is not recommended for my condition.I haven't tried all standard treatments yet.I am unable to understand and give informed consent.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
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.
Is enrollment for this experiment still available?
"The information posted on clinicaltrials.gov reveals that this experiment is currently enrolling volunteers, having been first published on April 1st 2021 and edited for the last time on April 21st 2022."
Answered by AI
What is the enrollment size for this clinical trial?
"Indeed, the information on clinicaltrials.gov indicates that recruitment for this medical trial is still active. It was posted to the site on April 1st 2021 and last updated on April 21th 2022; 60 patients need to be enrolled from one clinic."
Answered by AI
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