We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease
Parkinson's Disease Depression Anxiety

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mapping Mood in the Subthalamic Nucleus in PD
Study Start Date : December 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Tamara G Hershey, PhD Washington University School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00847431    
Other Study ID Numbers: 08-0354
R01NS058797-05 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2009    Key Record Dates
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:
Layout table for MeSH terms
Parkinson Disease
Depression
Behavioral Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases