Clinical trial NCT02686125: Vercise™ DBS Dystonia Prospective Study
Official title: Prospective Study of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dystonia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-02-19
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with intractable primary and secondary dystonia, for persons 7 years of age and older.

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.

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.

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.

Primary outcomes:
measure: Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score
timeFrame: up to 3 years
measure: Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
measure: Change in SF-36v2 score after DBS (SF-10v2 in patients under the age of 18 years at the time of consent)
timeFrame: upto 3 years
Locations:
city: Ghent
country: Belgium
facility: AZ Sint-Lucas
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
city: Berlin
country: Germany
facility: University Berlin, Charite Virchow Standort, Wedding
city: Dusseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Freiburg im Breisgau
country: Germany
facility: Universitaetsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitaetsklinik Eppendorf
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm-Heessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover MHH
city: Kiel
country: Germany
facility: Universitatsklinikum Campus Kiel
city: Köln
country: Germany
facility: Uniklinik Köln
city: Mainz
country: Germany
facility: Johannes Gutenberg Universitaet Mainz
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Oldenburg
country: Germany
facility: Evangelisches Krankenhaus Oldenburg
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Pecs
country: Hungary
facility: Medical School of University PECS
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
city: Mestre
country: Italy
facility: Ospedale Dell Angelo
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Udine
country: Italy
facility: Osp. S. Maria Della Misericordia
city: Incheon
country: Korea, Republic of
facility: St. Mary's Hospital Incheon
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis locatie Leyweg
city: Bydgoszcz
country: Poland
facility: 10 Military Clinical Hospital Bydgoszcz
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz)
city: Gdansk
country: Poland
facility: Podmiot Leczniczy Copernicus Sp. z o.o.
city: Warsaw
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
city: Moscow
country: Russian Federation
facility: National Scientific Center of Neurosurgery N.N. Burdenko
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: El Palmar
country: Spain
facility: University Hospital Virgen Arrixaca
city: Madrid
country: Spain
facility: Centro Especial Ramon y Cajal
city: Oviedo
country: Spain
facility: Hospital General De Asturias
city: Bristol
country: United Kingdom
facility: Southmead Hospital Bristol
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: