RecruitingNot Applicable

Vercise™ DBS Dystonia Prospective Study

Belgium, Canada, Germany300 participantsStarted 2016-03-07

Plain-language 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.

Who can participate

Age range7 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score

Timeframe: up to 3 years

Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score

Timeframe: up to 3 years

Trial details

NCT IDNCT02686125

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-12

Contact for this trial

Stephanie Delvaux

855-213-9890 BSNClinicalTrials@bsci.com

View on ClinicalTrials.gov More Dystonia trials