Vercise™ DBS Dystonia Prospective Study

NCT02686125 · tracked via the Priya Life Science UK tracker

Sponsor

Boston Scientific Corporation

Phase

Observational

Started

2016-03-07

Last updated

2026-09-11

Condition(s) studied

Dystonia

Investigational drug(s) / intervention(s)

Deep Brain Stimulation (DBS)

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

Study 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

Sex

ALL

Min age

7 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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 sites (36)

Facility	City	Region	Status
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Evangelisches Krankenhaus Oldenburg	Oldenburg	Germany	Withdrawn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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02686125 on ClinicalTrials.gov ↗ ← All trials in the UK