Back to resultsNeurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neural recordings and stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring Deep Brain Stimulation, Parkinson Disease, Cognitive impairment, Movement Disorders, Brain Diseases
Eligibility Criteria
Inclusion Criteria: • Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center (Arm 1) Active deep brain stimulation system with implantable pulse generator capable of recording local field potentials (Arm 2) Diagnosis of Parkinson's disease as determined by a movement disorders specialist neurologist Age at least 18 Able to participate in intraoperative testing English speaking Exclusion Criteria: Age less than 18 Not able to participate in intraoperative testing (ex unable to comprehend instructions or follow directions)
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment
Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation
Arm Description
Neurophysiology recordings will be performed from dorsolateral prefrontal cortex (DLPFC) during deep brain stimulation surgery, with and without STN or GPI stimulation, at rest and during a working memory task.
Neurophysiology recordings will be performed from subthalamic nucleus (STN) or globus pallidus internus (GPI) with stimulation on and off, at rest and during a working memory task, in patients who have previously been implanted with DBS and have implantable pulse generators capable of recording local field potentials.
Outcomes
Primary Outcome Measures
Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting
Working memory tasked will be conducted during surgery, and local field potentials (LFPs) will be recorded from the DLPFC both at rest and during task execution, under two conditions: with and without stimulation.
Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation
Local field potentials will be recorded from subthalamic nucleus or globus pallidus internus in patients with an existing DBS system with implantable pulse generator capable of recording local field potentials. Recordings will be performed at rest and during a working memory task, with DBS on and off.
Secondary Outcome Measures
Full Information
NCT ID
NCT05933681
First Posted
June 27, 2023
Last Updated
July 21, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05933681
Brief Title
Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
Official Title
Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (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
5. Study Description
Brief Summary
The study aims to investigate cognitive impairment associated with Deep Brain Stimulation (DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize DBS-related cognitive side effects.
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, Parkinson Disease, Cognitive impairment, Movement Disorders, Brain Diseases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment
Arm Type
Experimental
Arm Description
Neurophysiology recordings will be performed from dorsolateral prefrontal cortex (DLPFC) during deep brain stimulation surgery, with and without STN or GPI stimulation, at rest and during a working memory task.
Arm Title
Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation
Arm Type
Experimental
Arm Description
Neurophysiology recordings will be performed from subthalamic nucleus (STN) or globus pallidus internus (GPI) with stimulation on and off, at rest and during a working memory task, in patients who have previously been implanted with DBS and have implantable pulse generators capable of recording local field potentials.
Intervention Type
Device
Intervention Name(s)
Neural recordings and stimulation
Intervention Description
Neural activities from the dorsolateral prefrontal cortex and implanted DBS generator will be recorded, during resting and working memory tasks, and with the DBS target turned on and off.
Primary Outcome Measure Information:
Title
Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting
Description
Working memory tasked will be conducted during surgery, and local field potentials (LFPs) will be recorded from the DLPFC both at rest and during task execution, under two conditions: with and without stimulation.
Time Frame
Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Title
Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation
Description
Local field potentials will be recorded from subthalamic nucleus or globus pallidus internus in patients with an existing DBS system with implantable pulse generator capable of recording local field potentials. Recordings will be performed at rest and during a working memory task, with DBS on and off.
Time Frame
1 hour
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 (Arm 1)
Active deep brain stimulation system with implantable pulse generator capable of recording local field potentials (Arm 2)
Diagnosis of Parkinson's disease as determined by a movement disorders specialist neurologist
Age at least 18
Able to participate in intraoperative testing
English speaking
Exclusion Criteria:
Age less than 18
Not able to participate in intraoperative testing (ex unable to comprehend instructions or follow directions)
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
Zixiang Zhao, MS
Phone
4018370681
Email
zixiang.zhao@vumc.org
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 Bick, MD
Phone
615-322-1883
Email
Sarah.Bick@vumc.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
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