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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00847431

Collaborator

National Institutes of Health (NIH) (NIH), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Locations

Duration (Months)

40.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Parkinson's Disease Depression Anxiety

Study Design

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 :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	St. Louis	Missouri	United States	63110
2	University of Cincinnati, Movement Disorder Center	Cincinnati	Ohio	United States	45267-0525