Keywords: Deep Brain Stimulation , Parkinson's Disease
IRB Number: 00055315
Specialty: Neurology, Neurology, Neurology
Sub Specialties: Movement Disorders, Parkinson's Disease, Deep Brain Stimulation
Primary objective: To evaluate the safety and effectiveness of the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy for improving the number of waking hours per day with good symptom control and no troublesome dyskinesia (ON time) in adults with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
Secondary objectives: To evaluate the effectiveness of STN-DBS with the Vercise™ system on health outcomes including: general quality of life measures, levodopa equivalent medication use, the severity of PD symptoms and cost-effectiveness in subjects with advanced, levodopa-responsive Parkinson’s disease.