Clinical Trial Investigator: Cindy Zadikoff, MD, Co-PI
This is a multi-center, prospective, double-blind, randomized (3:1), controlled, adaptive design study using the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system as a therapy for improving functional status in patients with advanced, levodopa-responsive Parkinson’s disease (PD), which is not adequately controlled with medication.
The primary objective of the study is to evaluate the safety and effectiveness of the 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 which is not adequately controlled with medication.
Clinical Trial Eligibility Criteria:
- Bilateral idiopathic Parkinson’s disease
- Two (2) year history of resting tremor, rigidity, or bradykinesia
- Six (6) hours of poor motor function (OFF + ON w/troublesome dyskinesia)
- PD medications must improve PD symptoms by 33%
- Stable PD medications 28 days prior to informed consent
- Stable antidepressant medications eight (8) weeks prior to informed consent
Research Study Visits: 14 Clinic Visits and 1 phone call over 5.5 years
- CT scan
- Implantation procedure
Treatment: Medium-continuous stimulation or low-intermittent stimulation by the Boston Scientific DBS Vercise system (3:1 chance)
Compensation: $50-125 per study visit.
For More Information: Call us at 312-503-0755, or email email@example.com.Funded by: Boston Scientific Corporation