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Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04715984
Collaborator
(none)
75
Enrollment
1
Location
1
Arm
56
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Neurophysiology recordings
  • Procedure: Neural stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment
Actual Study Start Date :
Jun 2, 2021
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Neural recordings and stimulation

Other: Neurophysiology recordings
Neurophysiology recordings will be performed during deep brain stimulation surgery and their relationship to performance on a working memory task evaluated

Procedure: Neural stimulation
Neural stimulation will be delivered during a working memory task and its impact on task performance quantified

Outcome Measures

Primary Outcome Measures

  1. Changes in caudate DLPFC beta coherence [Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours]

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

  2. Changes in working memory performance with neural stimulatoin [Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours]

    The working memory task will involve seeing a series of words presented on the screen and pressing a button to respond. Working memory task performance will be compared between stimulated and non stimulated blocks and between stimulation targets

Secondary Outcome Measures

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

    Beta power will be computed and compared between stimulation on and off conditions for different targets

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Sarah Bick, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sarah Bick, Assistant Professor of Neurosurgery, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT04715984
Other Study ID Numbers:
  • 201868
First Posted:
Jan 20, 2021
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sarah Bick, Assistant Professor of Neurosurgery, Principal Investigator, Vanderbilt University Medical Center
Deep Brain Stimulation
Additional relevant MeSH terms:
Parkinson Disease
Cognitive Dysfunction
Cognition Disorders

Study Results

No Results Posted as of Jul 6, 2022