Vercise™ DBS Dystonia Prospective Study

NCT02686125 | Recruiting DMC

• 1 other identifier: A4012
• Study Type: observational
• Target: 300
• Locations: 12 countries
• Sites: 36

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.

Conditions

Dystonia

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (1)

• Change in SF-36v2 score after DBS (SF-10v2 in patients under the age of 18 years at the time of consent)

  upto 3 years

Interventions

Deep Brain Stimulation (DBS) DEVICE

Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia symptoms will be offered participation in this registry.

Also known as: Vercise DBS System Boston Scientific

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with intractable primary and secondary dystonia, for persons 7 years of age and older.

You may qualify if:

• 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.

You may not qualify if:

• EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (36)

AZ Sint-Lucas

Ghent, Belgium

TERMINATED

UZ Gasthuisberg

Leuven, Belgium

RECRUITING

Queen Elizabeth II Health Sciences Center

Halifax, Canada

RECRUITING

University Berlin, Charite Virchow Standort, Wedding

Berlin, Germany

RECRUITING

Uniklinik Köln

Cologne, Germany

RECRUITING

Universitaetsklinikum Dusseldorf

Düsseldorf, Germany

RECRUITING

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

RECRUITING

Universitaetsklinik Eppendorf

Hamburg, Germany

RECRUITING

St. Barbara-Klinik Hamm-Heessen

Hamm, Germany

COMPLETED

Medizinische Hochschule Hannover MHH

Hanover, Germany

RECRUITING

Universitatsklinikum Campus Kiel

Kiel, Germany

RECRUITING

Johannes Gutenberg Universitaet Mainz

Mainz, Germany

TERMINATED

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, Germany

RECRUITING

Evangelisches Krankenhaus Oldenburg

Oldenburg, Germany

WITHDRAWN

Universitaetsklinikum Wuerzburg

Würzburg, Germany

RECRUITING

Medical School of University PECS

Pécs, Hungary

RECRUITING

Hadassah Hebrew University Medical Center

Jerusalem, Israel

COMPLETED

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Italy

COMPLETED

Ospedale Dell Angelo

Mestre, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, Italy

COMPLETED

Osp. S. Maria Della Misericordia

Udine, Italy

TERMINATED

Haga Ziekenhuis locatie Leyweg

The Hague, Netherlands

RECRUITING

10 Military Clinical Hospital Bydgoszcz

Bydgoszcz, Poland

TERMINATED

Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz)

Bydgoszcz, Poland

TERMINATED

Podmiot Leczniczy Copernicus Sp. z o.o.

Gdansk, Poland

TERMINATED

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, Poland

TERMINATED

National Scientific Center of Neurosurgery N.N. Burdenko

Moscow, Russia

TERMINATED

St. Mary's Hospital Incheon

Incheon, South Korea

ACTIVE NOT RECRUITING

Hospital Clinic de Barcelona

Barcelona, Spain

COMPLETED

University Hospital Virgen Arrixaca

El Palmar, Spain

WITHDRAWN

Centro Especial Ramon y Cajal

Madrid, Spain

COMPLETED

Hospital General De Asturias

Oviedo, Spain

WITHDRAWN

Southmead Hospital Bristol

Bristol, United Kingdom

WITHDRAWN

Queen Elizabeth University Hospital

Glasgow, United Kingdom

COMPLETED

Charing Cross Hospital

London, United Kingdom

RECRUITING

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dystonia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Natalie Bloom Lyons

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Central Study Contacts

Stephanie Delvaux

CONTACT

855-213-9890; BSNClinicalTrials@bsci.com

Diane Keesey

CONTACT

855-213-9890; BSNClinicalTrials@bsci.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 19, 2016
• Study Start: March 7, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

GB (4); HU (1); DE (12); RU (1); KR (1); IT (4); BE (2); ES (4); NL (1); CA (1); IL (1); PL (4)