Vercise™ DBS Dystonia Prospective Study

Recruiting

• Conditions: Dystonia

• Registration Number: NCT02686125
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-19
• Study Start: 2016-03-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2030-12
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (36)

Queen Elizabeth II Health Sciences Center; 🇨🇦 Halifax, Canada

AZ Sint-Lucas; 🇧🇪 Ghent, Belgium

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

University Berlin, Charite Virchow Standort, Wedding; 🇩🇪 Berlin, Germany

Universitaetsklinikum Dusseldorf; 🇩🇪 Dusseldorf, Germany

Universitaetsklinikum Freiburg; 🇩🇪 Freiburg im Breisgau, Germany

Universitaetsklinik Eppendorf; 🇩🇪 Hamburg, Germany

St. Barbara-Klinik Hamm-Heessen; 🇩🇪 Hamm, Germany

Medizinische Hochschule Hannover MHH; 🇩🇪 Hannover, Germany

Universitatsklinikum Campus Kiel; 🇩🇪 Kiel, Germany

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