Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson’s Patients

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179101
First received: September 13, 2005
Last updated: August 11, 2006
Last verified: August 2006
  Purpose

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.


Condition Intervention
Parkinson's Disease
Procedure: Deep Brain Stimulation

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson’s Patients

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Estimated Enrollment: 42
Study Start Date: April 2004
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00179101

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Courtney R Schadt, BS Vanderbilt University
Study Director: David Charles, MD Vanderbilt University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179101     History of Changes
Other Study ID Numbers: 040251
Study First Received: September 13, 2005
Last Updated: August 11, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Parkinson's Disease
Depression
Quality of Life
Deep Brain Stimulation

Additional relevant MeSH terms:
Depressive Disorder
Parkinson Disease
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 24, 2014