Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
Purpose
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.
Condition
- Parkinson's Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Meets criteria established in locally applicable Vercise System Direction for Use - At least 18 years old
Exclusion Criteria
- 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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Parkinson's disease | Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation. |
|
Recruiting Locations
Los Angeles, California 90048
Aurora, Colorado 80220
Grand Junction, Colorado 81501
Gainesville, Florida 32610
Miami, Florida 33136
Tampa, Florida 33612
Boise, Idaho 83702
Chicago, Illinois 60612
Indianapolis, Indiana 46202
Albany, New York 12208
Great Neck, New York 11021
Williamsville, New York 14221
Winston-Salem, North Carolina 27157
Columbus, Ohio 43210
Houston, Texas 77030
San Antonio, Texas 78229
Sherman, Texas 75092
Kirkland, Washington 98034
Seattle, Washington 98195
Spokane, Washington 99202
More Details
- NCT ID
- NCT02071134
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
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.