Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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.
Trial design
1,500 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Alison Lewis; Heleen Scholtes
Data sourced from clinicaltrials.gov
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