- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179101
Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson's Patients
August 11, 2006 updated by: Vanderbilt University
We will evaluate the effect of deep brain stimulation on the depression and quality of life in Parkinson's disease.
We aim to compare depression pre-operatively and post-operatively in Parkinson's patients with deep brain stimulation to Parkinson's patients evaluated and approved for deep brain stimulation but who did not complete surgery.
We will also compare quality of life measures between patients with and without deep brain stimulation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Deep brain stimulation is an approved therapy for Parkinson's patients, and this procedure is actively performed at Vanderbilt University Hospital.
Questions have been raised concerning the effect of deep brain stimulation on the depression commonly seen in Parkinson's patients.
Through this study, we plan to evaluate and compare the incidence and severity of depression in Parkinson's patients with deep brain stimulation to those who did not complete the surgery.
Primary literature has indicated a general increase in quality of life of those patients receiving DBS, but no studies have compared these two specific patient populations.
Study Type
Observational
Enrollment
42
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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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University
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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
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients diagnosed with idiopathic Parkinson's disease.
- Patients who have received neuropsychological testing in preparation for possible deep brain stimulation.
- Patients are within the age of 50 and 85.
Exclusion Criteria:
- Parkinson's patients not approved for deep brain stimulation on the basis of neuropsychological testing.
- Patients who received deep brain stimulation less than a year ago.
- Patients who do not consent to the study procedures.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Courtney R Schadt, BS, Vanderbilt University
- Study Director: David Charles, MD, Vanderbilt University
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
April 1, 2004
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
August 15, 2006
Last Update Submitted That Met QC Criteria
August 11, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 040251
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.