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

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ClinicalTrials.gov Identifier: NCT01306539
Recruitment Status : Unknown
Verified March 2013 by Adam Aron, University of California, San Diego.
Recruitment status was:  Enrolling by invitation
First Posted : March 2, 2011
Last Update Posted : March 28, 2013
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Adam Aron, University of California, San Diego

February 28, 2011
March 2, 2011
March 28, 2013
July 2008
December 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01306539 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Stimulation of the subthalamic nucleus will have effects on various aspects of neuropsychiatric function.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Parkinson's Disease
Procedure: Stimulation of the subthalamic nucleus
Stimulation is delivered to the subthalamic nucleus at experimentally prescribed settings.
Experimental: Deep Brain Stimulation
Parkinson's patients with deep brain stimulation in the subthalamic nucleus.
Intervention: Procedure: Stimulation of the subthalamic nucleus
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.
 
Unknown status
45
Same as current
Not Provided
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01306539
HSC-07-4849
No
Not Provided
Not Provided
Adam Aron, University of California, San Diego
University of California, San Diego
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Adam Aron, PhD University of California, San Diego
University of California, San Diego
March 2013

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