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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00847431
First received: February 17, 2009
Last updated: June 2, 2015
Last verified: June 2015
  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:

Estimated Enrollment: 103
Study Start Date: December 2008
Estimated 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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Tamara G Hershey, PhD Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00847431     History of Changes
Other Study ID Numbers: 08-0354, R01NS058797-05
Study First Received: February 17, 2009
Last Updated: June 2, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 27, 2015