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

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: NCT00847431
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : May 4, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date February 17, 2009
First Posted Date February 19, 2009
Last Update Posted Date May 4, 2016
Study Start Date December 2008
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mapping Mood in the Subthalamic Nucleus in Parkinson's Disease (PD)
Official Title Mapping Mood in the Subthalamic Nucleus in PD
Brief Summary 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population PD patients with and without STN DBS
Condition
  • Parkinson's Disease
  • Depression
  • Anxiety
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 3, 2016)		 81
Original Estimated Enrollment
 (submitted: February 18, 2009)		 103
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00847431
Other Study ID Numbers 08-0354
R01NS058797-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Washington University School of Medicine
Original Responsible Party Tamara G Hershey PhD.,, Washington University School of Medicine
Current Study Sponsor Washington University School of Medicine
Original Study Sponsor Same as current
Collaborators
  • 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
PRS Account Washington University School of Medicine
Verification Date May 2016