At a glance
ClinicalIndex Comparison Record- ✓Idiopathic Parkinson's disease diagnosis
- ✓Hoehn and Yahr stage 2 or worse in off-medication state
- ✓L-dopa responsive but with disabling symptoms despite medical optimization (motor fluctuations, dyskinesias)
- ✓On stable medical therapy for at least 1 month prior to enrollment
- ✕Parkinson-plus syndromes or atypical parkinsonism
- ✕Medical contraindications to surgery or stimulation
- ✕Active alcohol or drug abuse
- ✕Minimental status exam score of 24 or lower, or dementia/neuropsychological dysfunction that would contraindicate surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #468 Phase I - A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson's Disease
In Brief
A Phase 3 clinical trial evaluating Bilateral Deep Brain Stimulation and best medical therapy for Parkinson's Disease. Completed, enrolled 255 participants across 14 sites.
Detailed Summary
The goals of this study are to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's disease, and if deep brain stimulation or best medical therapy is more effective in improving Parkinson's disease symptoms
Study Details
Timeline
Interventions
The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial.
Participants will initially be randomized to DBS or to 6 months of "best medical therapy." BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months.