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Mapping Mood in the Subthalamic Nucleus in Parkinson's Disease (PD) (MOOD-D)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847431
First Posted: February 19, 2009
Last Update Posted: May 4, 2016
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.
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
The goal of this study is to determine the vulnerability of mood-related neurocircuitry in Parkinson Disease (PD) using deep brain stimulation of the subthalamic nucleus (STN DBS).

Condition
Parkinson's Disease Depression Anxiety

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mapping Mood in the Subthalamic Nucleus in PD

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Enrollment: 81
Study Start Date: December 2008
Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
STN DBS Group
PD patients with deep brain stimulators in the subthalamic nucleus. Subjects within this group will be placed into either a 1 contact group, or 2 contact group, depending on contact location requirements for this study.
Control Group
PD patients without deep brain stimulator surgery, with similar symptoms to the study group.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PD patients with and without STN DBS
Criteria

Inclusion Criteria for STN-DBS subjects:

  • Age 40 or older
  • DBS STN Surgery in past 2 to 36 months
  • Ability to tolerate turning off Stimulators
  • Ability to read and comprehend questions
  • English speaking

Exclusion Criteria for STN-DBS subjects:

  • Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
  • Clinically determined Dementia ( Most recent MMSE score of >24)

Inclusion Criteria for Control subject:

  • Age 40 or older
  • Ability to read and comprehend questions
  • English speaking

Exclusion Criteria for Control subject:

  • Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
  • Clinically determined Dementia ( Most recent MMSE score of >24)
  • Plans to have DBS STN surgery in the next 24 months
  Contacts and Locations
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): NCT00847431


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Ohio
University of Cincinnati, Movement Disorder Center
Cincinnati, Ohio, United States, 45267-0525
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Tamara G Hershey, PhD Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00847431     History of Changes
Other Study ID Numbers: 08-0354
R01NS058797-05 ( U.S. NIH Grant/Contract )
First Submitted: February 17, 2009
First Posted: February 19, 2009
Last Update Posted: May 4, 2016
Last Verified: May 2016

Keywords provided by Washington University School of Medicine:
Subthalamic Nucleus
Deep Brain Stimulation
Depression
Anxiety
Parkinson's Disease

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