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

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ClinicalTrials.gov Identifier: NCT03204526
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Cognitive Impairment Device: deep brain stimulation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : June 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Beck's Depression Index [ Time Frame: After 72hours of test stimulation ]
    Questionnaire with numerical score indicating level of depression

  2. Mini Mental Status Exam [ Time Frame: After 72hours of test stimulation ]
    Questionnaire with numerical score indicating level of cognitive impairment

  3. Anxiety Scores [ Time Frame: After 72hours of test stimulation ]
    Questionnaire with numerical score indicating level of anxiety


Secondary Outcome Measures :
  1. N-back [ Time Frame: After 72 hours of test stimulation ]
    continuous performance task that measures working memory

  2. Stroop [ Time Frame: After 72 hours of test stimulation ]
    task measures reaction time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204526


Contacts
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Contact: Katherine Scangos, M.D, Ph.D. 9167346511
Contact: Kia Shahlaie, M.D., Ph.D. 9167346511

Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Katherine Scangos    916-734-6511      
Sponsors and Collaborators
University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03204526     History of Changes
Other Study ID Numbers: 693382
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Brain Diseases
Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders