Vercise™ DBS Dystonia Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep Brain Stimulation (DBS).
- Who it may be relevant to
- Registry conditions: Dystonia. Basic parameters: from 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Canada, Germany, Hungary, Israel +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Study of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia
Overview
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.
Interventions
- Device Deep Brain Stimulation (DBS)
Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia symptoms will be offered participation in this registry.
Primary outcome measures
- Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score [Time frame: up to 3 years]
- Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score [Time frame: up to 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 12 centers
- University Berlin, Charite Virchow Standort, Wedding — Berlin
- Uniklinik Köln — Cologne
- Universitaetsklinikum Dusseldorf — Düsseldorf
- Universitaetsklinikum Freiburg — Freiburg im Breisgau
- Universitaetsklinik Eppendorf — Hamburg
- St. Barbara-Klinik Hamm-Heessen — Hamm
- Medizinische Hochschule Hannover MHH — Hanover
- Universitatsklinikum Campus Kiel — Kiel
- … and 4 more centers
Italy · 4 centers
- Azienda Ospedaliero-Universitaria di Ferrara — Ferrara
- Ospedale Dell Angelo — Mestre
- Policlinico Universitario Agostino Gemelli — Rome
- Osp. S. Maria Della Misericordia — Udine
Poland · 4 centers
- 10 Military Clinical Hospital Bydgoszcz — Bydgoszcz
- Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz) — Bydgoszcz
- Podmiot Leczniczy Copernicus Sp. z o.o. — Gdansk
- Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie — Warsaw
Spain · 4 centers
- Hospital Clinic de Barcelona — Barcelona
- University Hospital Virgen Arrixaca — El Palmar
- Centro Especial Ramon y Cajal — Madrid
- Hospital General De Asturias — Oviedo
United Kingdom · 4 centers
- Southmead Hospital Bristol — Bristol
- Queen Elizabeth University Hospital — Glasgow
- Charing Cross Hospital — London
- Royal Victoria Infirmary — Newcastle upon Tyne
Belgium · 2 centers
- AZ Sint-Lucas — Ghent
- UZ Gasthuisberg — Leuven
Canada · 1 center
- Queen Elizabeth II Health Sciences Center — Halifax
Hungary · 1 center
- Medical School of University PECS — Pécs
Israel · 1 center
- Hadassah Hebrew University Medical Center — Jerusalem
Netherlands · 1 center
- Haga Ziekenhuis locatie Leyweg — The Hague
Russia · 1 center
- National Scientific Center of Neurosurgery N.N. Burdenko — Moscow
South Korea · 1 center
- St. Mary's Hospital Incheon — Incheon
Identifiers
NCT: NCT02686125 · A4012