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Clinical Trials/NCT04715984
NCT04715984
Recruiting
Not Applicable

Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment

Vanderbilt University Medical Center1 site in 1 country75 target enrollmentJune 2, 2021

Overview

Phase
Not Applicable
Intervention
Neural stimulation
Conditions
Parkinson Disease
Sponsor
Vanderbilt University Medical Center
Enrollment
75
Locations
1
Primary Endpoint
Changes in caudate DLPFC beta coherence
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.

Registry
clinicaltrials.gov
Start Date
June 2, 2021
End Date
August 1, 2029
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Bick

Assistant Professor of Neurosurgery, Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center
  • Planned clinical electrode trajectory that contacts caudate
  • Age greater than or equal to 40
  • Diagnosis of Parkinson's disease
  • Able to participate in intraoperative testing
  • English speaking

Exclusion Criteria

  • Age less than 40
  • Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)
  • Movement disorder other than Parkinson's disease

Arms & Interventions

Neural recordings and stimulation

Intervention: Neural stimulation

Neural recordings and stimulation

Intervention: Neurophysiology recordings

Outcomes

Primary Outcomes

Changes in caudate DLPFC beta coherence

Time Frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours

Caudate DLPFC coherence will be computed at rest and during the gambling task and correlated with cognitive metrics

Changes in gambling task performance with neural stimulation

Time Frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours

The gambling task will involve seeing a series of cards presented on the screen and pressing a button to respond with a bet. Gambling task performance will be compared between stimulated and non stimulated blocks and between stimulation targets

Secondary Outcomes

  • Change in beta power with neural stimulation(Baseline to end of deep brain stimulation (DBS) surgery, approximately 3-4 hours)

Study Sites (1)

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