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

Depression Clinical Trial

— MOOD-D  

Official title:

Mapping Mood in the Subthalamic Nucleus in PD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847431
• Other study ID #: 08-0354
• Secondary ID: R01NS058797-05
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: May 3, 2016
• Start date: December 2008
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Depression
• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	University of Cincinnati, Movement Disorder Center	Cincinnati	Ohio
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

External Links

•   Link to Dr. Hershey's Web Site