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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
Have a diagnosis of Parkinson's disease or Essential Tremor
A minimum of 18 years of age
Must not have
Are not able to participate in study-related activities
Are not surgical candidates due to co-morbid conditions or pregnancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have been diagnosed with Parkinson's disease or Essential Tremor.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take part in study activities.
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I cannot have surgery because of other health issues or because I am pregnant.
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Deep Brain Stimulation surgery is not recommended for my condition.
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I am unable to understand and give informed consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Accuracy via Simon Task (% correct)
Dementia Rating Scale Score 0-144 points (Higher score represents better symptoms)
Response times via Simon Task (sec)
+3 more

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
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
1,376 Previous Clinical Trials
651,395 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,645 Previous Clinical Trials
2,342,762 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

Procedure/Surgery: Response Inhibition and Deep Brain Stimulation in Parkinson's disease Clinical Trial Eligibility Overview. Trial Name: NCT04735458 — N/A
Parkinson's Disease Research Study Groups: Treatment, Control
Parkinson's Disease Clinical Trial 2023: Procedure/Surgery: Response Inhibition and Deep Brain Stimulation in Parkinson's disease Highlights & Side Effects. Trial Name: NCT04735458 — N/A
Procedure/Surgery: Response Inhibition and Deep Brain Stimulation in Parkinson's disease 2023 Treatment Timeline for Medical Study. Trial Name: NCT04735458 — N/A
~8 spots leftby Mar 2025