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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Adam Aron, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01306539
First received: February 28, 2011
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
 Procedure: Stimulation of the subthalamic nucleus
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • behavioral task performance [ Time Frame: 1 to 2 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: July 2008
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Adam Aron, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01306539     History of Changes
Other Study ID Numbers: HSC-07-4849
Study First Received: February 28, 2011
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013