Back to resultsNeuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stimulation of the subthalamic nucleus
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson's Disease focused on measuring deep brain stimulation, subthalamic nucleus
Eligibility Criteria
Inclusion Criteria:
- Participants diagnosed with idiopathic Parkinson's disease that meet criteria for treatment of their disease with STN-DBS. Participants will be selected for this study without regard for age (provided they are older than 18), gender or ethnic background.
- Participants must have undergone subthalamic nucleus DBS surgery and be receiving treatment at the Scripps Clinic in La Jolla, CA
Exclusion Criteria:
- Patients under 18 years old.
- Patients with mini-mental status scores below 26/30.
- Patients with known psychiatric disease.
- Patients who are too infirm, demented or dysarthric to clearly understand the consenting process, task instructions, or to communicate verbally regarding participation or non-participation.
Sites / Locations
- Scripps Clinic Torrey Pines
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep Brain Stimulation
Arm Description
Parkinson's patients with deep brain stimulation in the subthalamic nucleus.
Outcomes
Primary Outcome Measures
behavioral task performance
Participants will complete behavioral tasks at each of three visits to assess the effects of stimulation settings on task performance. At each research visit, behavior will be assessed beginning at 1 hour after the stimulation is adjusted to the experimental settings. Stimulation settings will be returned to each patient's treatment levels at the culmination of each visit.
Secondary Outcome Measures
Full Information
NCT ID
NCT01306539
First Posted
February 28, 2011
Last Updated
July 31, 2019
Sponsor
University of California, San Diego
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT01306539
Brief Title
Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Official Title
Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stimulation of the subthalamic nucleus will have effects on various aspects of neuropsychiatric function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
deep brain stimulation, subthalamic nucleus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Parkinson's patients with deep brain stimulation in the subthalamic nucleus.
Intervention Type
Procedure
Intervention Name(s)
Stimulation of the subthalamic nucleus
Intervention Description
Stimulation is delivered to the subthalamic nucleus at experimentally prescribed settings.
Primary Outcome Measure Information:
Title
behavioral task performance
Description
Participants will complete behavioral tasks at each of three visits to assess the effects of stimulation settings on task performance. At each research visit, behavior will be assessed beginning at 1 hour after the stimulation is adjusted to the experimental settings. Stimulation settings will be returned to each patient's treatment levels at the culmination of each visit.
Time Frame
1 to 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants diagnosed with idiopathic Parkinson's disease that meet criteria for treatment of their disease with STN-DBS. Participants will be selected for this study without regard for age (provided they are older than 18), gender or ethnic background.
Participants must have undergone subthalamic nucleus DBS surgery and be receiving treatment at the Scripps Clinic in La Jolla, CA
Exclusion Criteria:
Patients under 18 years old.
Patients with mini-mental status scores below 26/30.
Patients with known psychiatric disease.
Patients who are too infirm, demented or dysarthric to clearly understand the consenting process, task instructions, or to communicate verbally regarding participation or non-participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Aron, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic Torrey Pines
City
La Jolla
State/Province
California
ZIP/Postal Code
92092
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21184765
Citation
Greenhouse I, Gould S, Houser M, Hicks G, Gross J, Aron AR. Stimulation at dorsal and ventral electrode contacts targeted at the subthalamic nucleus has different effects on motor and emotion functions in Parkinson's disease. Neuropsychologia. 2011 Feb;49(3):528-34. doi: 10.1016/j.neuropsychologia.2010.12.030. Epub 2010 Dec 22.
Results Reference
result
Learn more about this trial
Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
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