NCT00179101

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

August 15, 2006

Status Verified

August 1, 2006

First QC Date

September 13, 2005

Last Update Submit

August 11, 2006

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseDepressionQuality of LifeDeep Brain Stimulation

Interventions

Deep Brain StimulationPROCEDURE

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseDepression

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Courtney R Schadt, BS

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

  • David Charles, MD

    Vanderbilt University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

April 1, 2004

Study Completion

November 1, 2005

Last Updated

August 15, 2006

Record last verified: 2006-08

Locations

US(1)