Deep Brain Stimulation for Parkinson's Disease Trial
- Conditions
- Parkinson's Disease
- Interventions
- Procedure: deep brain stimulation
- Registration Number
- NCT00053625
- Lead Sponsor
- University of Minnesota
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SA #1 Arm 2: Unilateral DBS in STN deep brain stimulation - SA #2 Arm 2: Bilateral DBS in STN deep brain stimulation Patients with STN bilateral DBS (previously had unilateral DBS in the STN, now have bilateral DBS in STN) SA #1 Arm 1: Unilateral DBS in GPi deep brain stimulation - SA #2 Arm 1: Bilateral DBS in GPi deep brain stimulation Patients with GPi bilateral DBS (previously had unilateral DBS in the GPi, now have bilateral DBS in GPi)
- Primary Outcome Measures
Name Time Method Mean change in total UPDRS score (baseline to six-months post DBS surgery) 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 Outcome Measures
Name Time Method Mean change in UPDRS subscales and individual scores Baseline to 6 months Subscales include domains including behavior and mood, activities of daily living, motor function, complications of therapy and others.
Individual scores to be evaluated include scores for tremor, rigidity, bradykensia, gait, and postural stability.
Other secondary endpoints include: Hoehn and Yahr staging, Modified Schwab and England Scale, timed test results, scores from psychiatric and quality of life assessments.
Trial Locations
- Locations (2)
Emory University School of Medicine, Neurology Department
🇺🇸Atlanta, Georgia, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States