Back to resultsLow Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
Primary Purpose
Parkinson Disease, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
deep brain stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms.
Exclusion Criteria:
Sites / Locations
- University of California, Davis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
low frequency stimulation (LFS)
Arm Description
Low-frequency deep brain stimulation of the subthalamic nucleus
Outcomes
Primary Outcome Measures
Mean Reaction Time for Computerized Color Naming Stroop Task
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Mean Accuracy Rates Using Computerized Color Naming Stroop Task
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Secondary Outcome Measures
Number of Participants With Worsening Depression Using Beck's Depression Index
Questionnaire with numerical score indicating level of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity.
Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III)
The UPDRS scale is a rating tool used to gauge the course of Parkinson's disease in patients and consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale.
Full Information
NCT ID
NCT03204526
First Posted
December 9, 2016
Last Updated
June 1, 2021
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03204526
Brief Title
Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
Official Title
Safety and Feasibility of Using Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus to Improve Cognitive Performance in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
5. Study Description
Brief Summary
Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced Parkinson's disease. All study participants have undergone DBS implantation surgery as part of their routine care for motor manifestations of Parkinson's disease. In this study, a temporary low frequency period of stimulation will be applied to determine its effects on cognition.
Detailed Description
In this randomized cross-over pilot study, our primary aim was to determine the effect of theta (5 Hz), and gamma (130 Hz) frequency stimulation in the ventral STN on cognitive control in patients with PD. This study provides a first look at frequency dependent modulation of cognitive function and provides important insights into the utility of DBS for non-motor symptoms of PD and other neuropsychiatric disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low frequency stimulation (LFS)
Arm Type
Experimental
Arm Description
Low-frequency deep brain stimulation of the subthalamic nucleus
Intervention Type
Device
Intervention Name(s)
deep brain stimulation
Primary Outcome Measure Information:
Title
Mean Reaction Time for Computerized Color Naming Stroop Task
Description
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Time Frame
2 days
Title
Mean Accuracy Rates Using Computerized Color Naming Stroop Task
Description
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Number of Participants With Worsening Depression Using Beck's Depression Index
Description
Questionnaire with numerical score indicating level of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity.
Time Frame
2 days
Title
Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III)
Description
The UPDRS scale is a rating tool used to gauge the course of Parkinson's disease in patients and consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale.
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms.
Exclusion Criteria:
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
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