Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
- Conditions
- Parkinson's Disease
- Registration Number
- NCT02071134
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.
The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated.
Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.
- Detailed Description
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.
Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Image Guided Programming (IGP) when used as a planning tool for programming of patients is also evaluated.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Meets criteria established in locally applicable Vercise System Direction for Use
- At least 18 years old
Key
- Meets any contraindication in the Vercise System locally applicable Directions for Use
Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in patient's quality of life (QoL) during the study as compared with baseline up to 3 years Change in quality of life assessments during the study as compared with baseline
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (81)
Neurology and Pain Specialty
🇺🇸Aliso Viejo, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
University of Florida Shands Hospital
🇺🇸Gainesville, Florida, United States
Mayo Clinic, Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Tallahassee Neurological Clinic, PA
🇺🇸Tallahassee, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
St. Luke Regional Medical Center
🇺🇸Boise, Idaho, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
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