What this study is
The purpose of this study is to investigate the brain activity associated with non-motor symptoms of movement disorders, including Parkinson's disease and essential tremor. These movement disorders commonly have significant non-motor features also, including depression, cognitive impairment, decreased attention, and slower processing speeds. The investigators are interested in the brain activity associated with these symptoms, and perform recordings of the surface of the brain, in addition to the typical recordings the investigators perform, during routine deep brain stimulation (DBS) surgery.
What's being tested
- Procedure/Surgery: Response Inhibition and Deep Brain Stimulation in Parkinson's disease
Intervention · OTHER
After creation of the burr hole and prior to DBS electrode placement, 1-2 subdural strip electrodes will be placed anteriorly or posteriorly from the cranial opening. These electrodes are routinely placed using this technique for seizure mapping, with arrays of electrodes (up to 6) being placed around the perimeter of the opening.14 Subdural strips vary in length and contact size (e.g., the 6-contact Ad-Tech strip), and are currently placed predominantly for studies of sensorimotor function,13 including at our institution (IRB-140327003). Placement over prefrontal areas is performed at other institutions.11-13 The DBS surgery will then proceed according to routine practice, and following lead placement in the optimal desired location, the research task paradigm will begin.
Study details
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Parkinson Disease
- Enrolling
- 140 people
- Starts
- 2021-04-01
- Est. completion
- 2028-03-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Eligible for surgery based on multi-disciplinary consensus review
- Have a diagnosis of Parkinson's disease or Essential Tremor
- Have a diagnosis of medically-refractory movement disorder (Parkinson's disease, Essential Tremor, or dystonia)
- Willingness to participate in the paradigms described in the protocol
You can't join if
- Inability to provide full and informed consent
- Age younger than 18
- Are not able to participate in study-related activities
- History of prior ischemic/hemorrhagic stroke, subdural hemorrhage, or seizure
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
- Nicole Bentley, MD · Contact205-975-0011jbentley@uabmc.edu
Recruiting
Study team
Sponsor
University of Alabama at Birmingham
Study ID IRB300003605
Principal investigator
Nicole Bentley, MD
University of Alabama at Birmingham
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.