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Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurophysiology recordings
Neural stimulation
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Deep Brain Stimulation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neural recordings and stimulation

Arm Description

Outcomes

Primary Outcome Measures

Changes in caudate DLPFC beta coherence
Caudate DLPFC coherence will be computed at rest and during the working memory task and correlated with cognitive metrics
Changes in working memory performance with neural stimulatoin
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

Change in beta power with neural stimulation
Beta power will be computed and compared between stimulation on and off conditions for different targets

Full Information

First Posted
January 14, 2021
Last Updated
July 21, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04715984
Brief Title
Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment
Official Title
Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neural recordings and stimulation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Neurophysiology recordings
Intervention Description
Neurophysiology recordings will be performed during deep brain stimulation surgery and their relationship to performance on a working memory task evaluated
Intervention Type
Procedure
Intervention Name(s)
Neural stimulation
Intervention Description
Neural stimulation will be delivered during a working memory task and its impact on task performance quantified
Primary Outcome Measure Information:
Title
Changes in caudate DLPFC beta coherence
Description
Caudate DLPFC coherence will be computed at rest and during the working memory task and correlated with cognitive metrics
Time Frame
Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Title
Changes in working memory performance with neural stimulatoin
Description
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
Time Frame
Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Secondary Outcome Measure Information:
Title
Change in beta power with neural stimulation
Description
Beta power will be computed and compared between stimulation on and off conditions for different targets
Time Frame
Baseline to end of deep brain stimulation (DBS) surgery, approximately 3-4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Bick, MD
Phone
615-322-1883
Email
Sarah.Bick@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Deeptha Subramanian, BA
Phone
615-322-1952
Email
deeptha.subramanian@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Bick, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah K Bick, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment

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