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Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01306539
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : August 2, 2019
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Adam Aron, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE February 28, 2011
First Posted Date  ICMJE March 2, 2011
Last Update Posted Date August 2, 2019
Actual Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2011)		 behavioral task performance [ Time Frame: 1 to 2 hours ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Official Title  ICMJE Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Brief Summary Stimulation of the subthalamic nucleus will have effects on various aspects of neuropsychiatric function.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Basic Science
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Procedure: Stimulation of the subthalamic nucleus
Stimulation is delivered to the subthalamic nucleus at experimentally prescribed settings.
Study Arms  ICMJE Experimental: Deep Brain Stimulation
Parkinson's patients with deep brain stimulation in the subthalamic nucleus.
Intervention: Procedure: Stimulation of the subthalamic nucleus
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2019)		 20
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2011)		 45
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01306539
Other Study ID Numbers  ICMJE HSC-07-4849
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Adam Aron, University of California, San Diego
Original Responsible Party Adam Aron, University of California San Diego
Current Study Sponsor  ICMJE University of California, San Diego
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Alliance for Research on Schizophrenia and Depression
Investigators  ICMJE
Principal Investigator: Adam Aron, PhD University of California, San Diego
PRS Account University of California, San Diego
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP