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

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT03204526
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 53
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Cognitive Impairment	Device: deep brain stimulation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2015
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low frequency stimulation (LFS) Low-frequency deep brain stimulation of the subthalamic nucleus	Device: deep brain stimulation

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Davis	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 14, 2015
• Informed Consent Form - May 6, 2015

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03204526
• Other Study ID Numbers: 693382
• First Posted: Jul 2, 2017
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Parkinson Disease

Study Results

Participant Flow

Arm/Group Title	Low Frequency Stimulation (LFS)
Arm/Group Description	Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Low Frequency Stimulation (LFS)
Arm/Group Description	Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Overall Participants	15
Age (Year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Year]	62.18 (6.42)
Sex: Female, Male (Count of Participants)
Female	2 13.3%
Male	13 86.7%
Race and Ethnicity Not Collected (Count of Participants)
Race and Ethnicity Not Collected (Count of Participants)
Disease Duration (Year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Year]	7.73 (3.38)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Frequency Stimulation (LFS)
Arm/Group Description	Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Measure Participants	15
Mean (95% Confidence Interval) [seconds]	5.09

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Frequency Stimulation (LFS)
Arm/Group Description	Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Measure Participants	15
Mean (95% Confidence Interval) [percent correct response]	4.61

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Frequency Stimulation (LFS)
Arm/Group Description	Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Measure Participants	10
Count of Participants [Participants]	0 0%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Frequency Stimulation (LFS)
Arm/Group Description	Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Measure Participants	15
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	Study duration (maximum of 2 months)
Adverse Event Reporting Description	No Adverse Events
Arm/Group Title	Low Frequency Stimulation (LFS)
Arm/Group Description	Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
All Cause Mortality
	Low Frequency Stimulation (LFS)
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	Low Frequency Stimulation (LFS)
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Low Frequency Stimulation (LFS)
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.