Vercise™ DBS Dystonia Prospective Study

NCT ID: NCT02686125

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-07

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Dystonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Deep Brain Stimulation (DBS)

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

Intervention Type DEVICE

Other Intervention Names

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Vercise DBS System Boston Scientific

Eligibility Criteria

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Inclusion Criteria

* 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

* EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Bloom Lyons

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

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AZ Sint-Lucas

Ghent, , Belgium

Site Status TERMINATED

UZ Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

Queen Elizabeth II Health Sciences Center

Halifax, , Canada

Site Status RECRUITING

University Berlin, Charite Virchow Standort, Wedding

Berlin, , Germany

Site Status RECRUITING

Uniklinik Köln

Cologne, , Germany

Site Status RECRUITING

Universitaetsklinikum Dusseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Universitaetsklinik Eppendorf

Hamburg, , Germany

Site Status RECRUITING

St. Barbara-Klinik Hamm-Heessen

Hamm, , Germany

Site Status COMPLETED

Medizinische Hochschule Hannover MHH

Hanover, , Germany

Site Status RECRUITING

Universitatsklinikum Campus Kiel

Kiel, , Germany

Site Status RECRUITING

Johannes Gutenberg Universitaet Mainz

Mainz, , Germany

Site Status TERMINATED

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Oldenburg

Oldenburg, , Germany

Site Status WITHDRAWN

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status RECRUITING

Medical School of University PECS

Pécs, , Hungary

Site Status RECRUITING

Hadassah Hebrew University Medical Center

Jerusalem, , Israel

Site Status COMPLETED

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, , Italy

Site Status COMPLETED

Ospedale Dell Angelo

Mestre, , Italy

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, , Italy

Site Status COMPLETED

Osp. S. Maria Della Misericordia

Udine, , Italy

Site Status TERMINATED

Haga Ziekenhuis locatie Leyweg

The Hague, , Netherlands

Site Status RECRUITING

10 Military Clinical Hospital Bydgoszcz

Bydgoszcz, , Poland

Site Status TERMINATED

Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz)

Bydgoszcz, , Poland

Site Status TERMINATED

Podmiot Leczniczy Copernicus Sp. z o.o.

Gdansk, , Poland

Site Status TERMINATED

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, , Poland

Site Status TERMINATED

National Scientific Center of Neurosurgery N.N. Burdenko

Moscow, , Russia

Site Status TERMINATED

St. Mary's Hospital Incheon

Incheon, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status COMPLETED

University Hospital Virgen Arrixaca

El Palmar, , Spain

Site Status WITHDRAWN

Centro Especial Ramon y Cajal

Madrid, , Spain

Site Status COMPLETED

Hospital General De Asturias

Oviedo, , Spain

Site Status WITHDRAWN

Southmead Hospital Bristol

Bristol, , United Kingdom

Site Status WITHDRAWN

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status COMPLETED

Charing Cross Hospital

London, , United Kingdom

Site Status RECRUITING

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Countries

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Belgium Canada Germany Hungary Israel Italy Netherlands Poland Russia South Korea Spain United Kingdom

Central Contacts

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Stephanie Delvaux

Role: CONTACT

855-213-9890

Diane Keesey

Role: CONTACT

855-213-9890

Facility Contacts

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Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Other Identifiers

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A4012

Identifier Type: -

Identifier Source: org_study_id

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