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: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2030-12
• Study Completion: 2030-12

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)

Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Italy

Osp. S. Maria Della Misericordia; 🇮🇹 Udine, Italy

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

Uniklinik Köln; 🇩🇪 Köln, Germany

Johannes Gutenberg Universitaet Mainz; 🇩🇪 Mainz, Germany

Universitaetsklinikum Giessen und Marburg GmbH; 🇩🇪 Marburg, Germany

Evangelisches Krankenhaus Oldenburg; 🇩🇪 Oldenburg, Germany

Universitaetsklinikum Wuerzburg; 🇩🇪 Würzburg, Germany

Medical School of University PECS; 🇭🇺 Pecs, Hungary

Hadassah Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel

Azienda Ospedaliero-Universitaria di Ferrara; 🇮🇹 Ferrara, Italy

Ospedale Dell Angelo; 🇮🇹 Mestre, Italy

St. Mary's Hospital Incheon; 🇰🇷 Incheon, Korea, Republic of

Haga Ziekenhuis locatie Leyweg; 🇳🇱 Den Haag, Netherlands

10 Military Clinical Hospital Bydgoszcz; 🇵🇱 Bydgoszcz, Poland

Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz); 🇵🇱 Bydgoszcz, Poland

Podmiot Leczniczy Copernicus Sp. z o.o.; 🇵🇱 Gdansk, Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; 🇵🇱 Warsaw, Poland

National Scientific Center of Neurosurgery N.N. Burdenko; 🇷🇺 Moscow, Russian Federation

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

University Hospital Virgen Arrixaca; 🇪🇸 El Palmar, Spain

Centro Especial Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital General De Asturias; 🇪🇸 Oviedo, Spain

Southmead Hospital Bristol; 🇬🇧 Bristol, United Kingdom

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom

Charing Cross Hospital; 🇬🇧 London, United Kingdom

Royal Victoria Infirmary; 🇬🇧 Newcastle Upon Tyne, United Kingdom