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

    • New York
      • New York, New York, United States, 10029
        • Mt. Sinai School of Medicine

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.

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

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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