Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
- Conditions
- Parkinson's Disease
- Registration Number
- NCT01839396
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
- Detailed Description
The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.
GUIDE XT may be used for planning of programming as needed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 313
- Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
- Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
- Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Key
- Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
- Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
- Any other active implanted devices including neurostimulators and /or drug delivery pumps
- Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in ON Time as Measured by Parkinson's Disease Diary From baseline to 12 weeks post-randomization Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement
- Secondary Outcome Measures
Name Time Method Secondary Endpoints From baseline to 12 weeks post-randomization Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization.
Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state.
Related Research Topics
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Trial Locations
- Locations (22)
Muhammad Ali Parkinson Research Center and Movement Disorders Clinic
🇺🇸Phoenix, Arizona, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente, Sacramento
🇺🇸Sacramento, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Carepoint, PC d/b/a Blue Sky Neurology
🇺🇸Englewood, Colorado, United States
University of Florida Shands Hospital
🇺🇸Gainesville, Florida, United States
Mayo Clinic, Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Miami, School of Medicine
🇺🇸Miami, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Scroll for more (12 remaining)Muhammad Ali Parkinson Research Center and Movement Disorders Clinic🇺🇸Phoenix, Arizona, United States