Deep Brain Stimulation for Parkinson's Disease Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- University of Minnesota
- Enrollment
- 123
- Locations
- 2
- Primary Endpoint
- Mean change in total UPDRS score (baseline to six-months post DBS surgery)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this trial is to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and psychiatric function, and quality of life in patients with Parkinson's disease.
Detailed Description
Medical therapy is the mainstay of treatment for patients with Parkinson's disease (PD). After several years of drug therapy, however, a large proportion of patients experience worsening of their parkinsonism and develop incapacitating motor fluctuations and dyskinesias. To deal with this, attention has been directed to surgical procedures, such as deep brain stimulation (DBS). Recently, stimulating the areas of the brain that control movement, the globus pallidus (Gpi) and subthalamic nucleus (STN), has been proposed as a therapy for treating many of the disabling symptoms associated with PD and drug-induced side effects. The major aim of this 5-year study is to carry out a prospective, double blinded, randomized, clinical trial of DBS for medically intractable PD. The study will evaluate the effect of DBS in the Gpi and STN on motor, neuropsychological and psychiatric function, and quality of life in patients with PD. The study also will address two key issues: 1) whether there are differences between unilateral Gpi-DBS and STN-DBS and 2) which patients are the best candidates for bilateral DBS.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean change in total UPDRS score (baseline to six-months post DBS surgery)
Time Frame: Followed for minimum of 5 years
The Unified Parkinson's Disease Rating Scale (UPDRS) is a commonly used survey tool used to assess symptom severity of patients with Parkinson's disease (PD). It covers several different domains including 1) thought, behavior and mood 2) activities of daily living 3) motor activity 4) complications of therapy and others. The mean change from baseline to six months after DBS surgery for patients with DBS in the GPi vs the STN will be compared after being adjusted for differences in age and time since PD diagnosis.
Secondary Outcomes
- Mean change in UPDRS subscales and individual scores(Baseline to 6 months)