Vercise™ DBS Dystonia Prospective Study

Last updated: April 1, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dystonia

Dyskinesias

Treatment

Deep Brain Stimulation (DBS)

Clinical Study ID

NCT02686125
A4012
  • Ages > 7
  • All Genders

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 Criteria

Inclusion

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.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Deep Brain Stimulation (DBS)
Phase:
Study Start date:
March 07, 2016
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • AZ Sint-Lucas

    Gent,
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Ghent,
    Belgium

    Active - Recruiting

  • UZ Gasthuisberg

    Leuven,
    Belgium

    Active - Recruiting

  • University Berlin, Charite Virchow Standort, Wedding

    Berlin,
    Germany

    Active - Recruiting

  • Universitaetsklinikum Dusseldorf

    Dusseldorf,
    Germany

    Active - Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau,
    Germany

    Active - Recruiting

  • Universitaetsklinik Eppendorf

    Hamburg,
    Germany

    Active - Recruiting

  • St. Barbara-Klinik Hamm-Heessen

    Hamm,
    Germany

    Completed

  • Medizinische Hochschule Hannover MHH

    Hannover,
    Germany

    Active - Recruiting

  • Universitatsklinikum Campus Kiel

    Kiel,
    Germany

    Active - Recruiting

  • Uniklinik Köln

    Köln,
    Germany

    Active - Recruiting

  • Johannes Gutenberg Universitaet Mainz

    Mainz,
    Germany

    Terminated

  • Universitaetsklinikum Giessen und Marburg GmbH

    Marburg,
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Oldenburg

    Oldenburg,
    Germany

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Wuerzburg,
    Germany

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Würzburg,
    Germany

    Active - Recruiting

  • Medical School of University PECS

    Pecs,
    Hungary

    Active - Recruiting

  • Hadassah Hebrew University Medical Center

    Jerusalem,
    Israel

    Completed

  • Azienda Ospedaliero-Universitaria di Ferrara

    Ferrara,
    Italy

    Completed

  • Ospedale Dell Angelo

    Mestre,
    Italy

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli

    Rome,
    Italy

    Completed

  • Osp. S. Maria Della Misericordia

    Udine,
    Italy

    Terminated

  • St. Mary's Hospital Incheon

    Incheon,
    Korea, Republic of

    Site Not Available

  • Haga Ziekenhuis locatie Leyweg

    Den Haag,
    Netherlands

    Active - 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,
    Russian Federation

    Terminated

  • Hospital Clinic de Barcelona

    Barcelona,
    Spain

    Completed

  • University Hospital Virgen Arrixaca

    El Palmar,
    Spain

    Site Not Available

  • Centro Especial Ramon y Cajal

    Madrid,
    Spain

    Completed

  • Hospital General De Asturias

    Oviedo,
    Spain

    Site Not Available

  • Southmead Hospital Bristol

    Bristol,
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow,
    United Kingdom

    Completed

  • Charing Cross Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Royal Victoria Infirmary

    Newcastle Upon Tyne,
    United Kingdom

    Active - Recruiting

  • Boston Scientific Clinical Research Information

    Valencia, California 91355
    United States

    Site Not Available

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