Dystonia
Conditions
Brief summary
To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.
Detailed description
To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia. Subjects' improvement in disease symptoms and overall Quality of life will be assessed.
Interventions
Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia 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
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(IC): * IC1. Meets criteria established in the locally applicable Vercise System Directions for Use (DFU) for dystonia. * IC2. At least 7 years old. Parent or guardian consent is required in patients who are younger than 18 years at the time of consent.
Exclusion criteria
(EC): * EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score | up to 3 years |
| Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score | up to 3 years |
Countries
Belgium, Canada, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom
Contacts
CONTACTStephanie Delvaux
CONTACTDiane Keesey
STUDY_DIRECTORNatalie Bloom Lyons
Boston Scientific Neuromodulation Corporation
Outcome results
None listed