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Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

Recruiting
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
Inclusion Criteria
  • Meets criteria established in locally applicable Vercise System Direction for Use
  • At least 18 years old

Key

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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in patient's quality of life (QoL) during the study as compared with baselineup to 3 years

Change in quality of life assessments during the study as compared with baseline

Secondary Outcome Measures
NameTimeMethod

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

Scroll for more (71 remaining)
Neurology and Pain Specialty
🇺🇸Aliso Viejo, California, United States

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