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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00847431
First received: February 17, 2009
Last updated: November 2, 2011
Last verified: November 2011
  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 2013
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

Contacts
Contact: Samantha Blankenship, MSW 314-362-6514 blankenships@npg.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Samantha Blankenship, MSW    314-362-6514    blankenships@npg.wustl.edu   
Principal Investigator: Tamara G Hershey, PhD         
United States, Ohio
University of Cincinnati, Movement Disorder Center Recruiting
Cincinnati, Ohio, United States, 45267-0525
Contact: Maureen Gartner, RN, M.Ed.    513-558-0018    gartnem@ucmail.uc.edu   
Principal Investigator: Fredy Revilla, MD         
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, RO1 NS058797
Study First Received: February 17, 2009
Last Updated: November 2, 2011
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:
Anxiety Disorders
Depression
Depressive Disorder
Parkinson Disease
Mental Disorders
Behavioral Symptoms
Mood Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 20, 2014