RecruitingNCT02686125
Vercise™ DBS Dystonia Prospective Study
Prospective Study of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia
Sponsor
Boston Scientific Corporation
Enrollment
300 participants
Start Date
Mar 7, 2016
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 7 Years
Inclusion Criteria2
- 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 Criteria1
- EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.
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Interventions
DEVICEDeep Brain Stimulation (DBS)
Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia symptoms will be offered participation in this registry.
Locations(36)
View Full Details on ClinicalTrials.gov
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NCT02686125
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