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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

Brief Summary:
Stimulation of the subthalamic nucleus will have effects on various aspects of neuropsychiatric function.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Procedure: Stimulation of the subthalamic nucleus Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease
Study Start Date : July 2008
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Deep Brain Stimulation
Parkinson's patients with deep brain stimulation in the subthalamic nucleus.
Procedure: Stimulation of the subthalamic nucleus
Stimulation is delivered to the subthalamic nucleus at experimentally prescribed settings.



Primary Outcome Measures :
  1. 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.



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

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): NCT01306539


Locations
United States, California
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92092
Sponsors and Collaborators
University of California, San Diego
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Adam Aron, PhD University of California, San Diego

Publications of Results:
Responsible Party: Adam Aron, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01306539     History of Changes
Other Study ID Numbers: HSC-07-4849
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

Keywords provided by Adam Aron, University of California, San Diego:
deep brain stimulation
subthalamic nucleus

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases