- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00954772
Mood and Subthalamic Nucleus (STN) Deep Brain Stimulation (MOST)
November 30, 2011 updated by: University of Florida
Mood and STN Deep Brain Stimulation
The purpose of this research study is to investigate any changes seen in mood or behavior following deep brain stimulation for movement disorders.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
91
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10029
- Mt. Sinai School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Parkinson's patients who undergo STN DBS
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Staged Bilateral STN DBS
|
Simultaneous Bilateral STN DBS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael S Okun, MD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
August 5, 2009
First Submitted That Met QC Criteria
August 6, 2009
First Posted (Estimate)
August 7, 2009
Study Record Updates
Last Update Posted (Estimate)
December 2, 2011
Last Update Submitted That Met QC Criteria
November 30, 2011
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00056229
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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