Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
Safety and Feasibility of Using Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus to Improve Cognitive Performance in Patients With Parkinson's Disease
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Jun 2015
Longer than P75 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 9, 2016
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedResults Posted
Study results publicly available
June 23, 2021
CompletedJune 23, 2021
June 1, 2021
4.4 years
December 9, 2016
February 8, 2021
June 1, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
2 days
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.
2 days
Secondary Outcomes (2)
Number of Participants With Worsening Depression Using Beck's Depression Index
2 days
Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III)
2 days
Study Arms (1)
low frequency stimulation (LFS)
EXPERIMENTALLow-frequency deep brain stimulation of the subthalamic nucleus
Interventions
Eligibility Criteria
You may qualify if:
- Parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Davis
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kiarash Shahlaie, MD, PhD, FAANS, Bronte Professor of Neurological Surgery
- Organization
- UC Davis Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2016
First Posted
July 2, 2017
Study Start
June 1, 2015
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
June 23, 2021
Results First Posted
June 23, 2021
Record last verified: 2021-06