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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179101
• Other study ID #: 040251
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: August 11, 2006
• Start date: April 2004
• Est. completion date: November 2005

Study information

• Verified date: August 2006
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• Deep Brain Stimulation

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States,