Mood and Subthalamic Nucleus (STN) Deep Brain Stimulation (MOST)

This study has been completed.
Sponsor:
Collaborator:
National Parkinson Foundation
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00954772
First received: August 5, 2009
Last updated: November 30, 2011
Last verified: August 2009
  Purpose

The purpose of this research study is to investigate any changes seen in mood or behavior following deep brain stimulation for movement disorders.


Condition
Movement Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mood and STN Deep Brain Stimulation

Resource links provided by NLM:


Further study details as provided by University of Florida:

Enrollment: 91
Study Start Date: July 2005
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Staged Bilateral STN DBS
Simultaneous Bilateral STN DBS

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Parkinson's patients who undergo STN DBS

Criteria

Inclusion Criteria:

  • Idiopathic PD diagnosed by a movement disorders neurologist
  • Approved by a movement disorders neurologist as clinically needing a DBS device
  • Absence of significant cognitive dysfunction (Mattis Dementia Rating Scale Score of greater than or equal to 116)
  • MRI without evidence of structural abnormality (stroke, tumor, malformation, etc)
  • No prior neurosurgical intervention

Exclusion Criteria:

  • None
  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: NCT00954772

Locations
United States, New York
Mt. Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
University of Florida
National Parkinson Foundation
Investigators
Principal Investigator: Michael S Okun, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00954772     History of Changes
Other Study ID Numbers: 00056229
Study First Received: August 5, 2009
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Staged versus Simultaneous Bilateral DBS

Additional relevant MeSH terms:
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014