Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease; Cognitive Impairment
• Interventions: Device: deep brain stimulation

• Registration Number: NCT03204526
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-07-02
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Results First Submitted: 2021-02-08
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Results First Posted: 2021-06-23
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
low frequency stimulation (LFS)	deep brain stimulation	Low-frequency deep brain stimulation of the subthalamic nucleus

Primary Outcome Measures

Name	Time	Method
Mean Reaction Time for Computerized Color Naming Stroop Task	2 days	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	2 days	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

Name	Time	Method
Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III)	2 days	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.
Number of Participants With Worsening Depression Using Beck's Depression Index	2 days	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.

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Sacramento, California, United States