Parkinson's Disease
Conditions
Keywords
Deep brain stimulation, Parkinson's disease, Vercise
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.
Interventions
Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their Parkinson's disease symptoms will be offered participation in this registry.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Argentina, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Poland, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTHeleen Scholtes
CONTACTAlison Lewis
STUDY_DIRECTORNatalie Bloom Lyons
Boston Scientific Neuromodulation Corporation
Outcome results
None listed