Vercise™ DBS Dystonia Prospective Study

Dystonia Clinical Trial

Official title:

Prospective Study of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02686125
• Other study ID #: A4012
• Status: Recruiting
• Start date: March 7, 2016
• Est. completion date: December 2030

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Stephanie Delvaux
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders

Intervention

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.

Locations

Country	Name	City	State
Belgium	AZ Sint-Lucas	Ghent
Germany	University Berlin, Charite Virchow Standort, Wedding	Berlin
Germany	Universitaetsklinikum Dusseldorf	Dusseldorf
Germany	Universitaetsklinikum Freiburg	Freiburg im Breisgau
Germany	Universitaetsklinik Eppendorf	Hamburg
Germany	St. Barbara-Klinik Hamm-Heessen	Hamm
Germany	Medizinische Hochschule Hannover MHH	Hannover
Germany	Universitatsklinikum Campus Kiel	Kiel
Germany	Uniklinik Köln	Köln
Germany	Johannes Gutenberg Universitaet Mainz	Mainz
Germany	Universitaetsklinikum Giessen und Marburg GmbH	Marburg
Germany	Evangelisches Krankenhaus Oldenburg	Oldenburg
Germany	Universitaetsklinikum Wuerzburg	Würzburg
Hungary	Medical School of University PECS	Pecs
Israel	Hadassah Hebrew University Medical Center	Jerusalem
Italy	Azienda Ospedaliero-Universitaria di Ferrara	Ferrara
Italy	Ospedale Dell Angelo	Mestre
Italy	Policlinico Universitario Agostino Gemelli	Rome
Italy	Osp. S. Maria Della Misericordia	Udine
Korea, Republic of	St. Mary's Hospital Incheon	Incheon
Netherlands	Haga Ziekenhuis locatie Leyweg	Den Haag
Poland	10 Military Clinical Hospital Bydgoszcz	Bydgoszcz
Poland	Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz)	Bydgoszcz
Poland	Podmiot Leczniczy Copernicus Sp. z o.o.	Gdansk
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie	Warsaw
Russian Federation	National Scientific Center of Neurosurgery N.N. Burdenko	Moscow
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	University Hospital Virgen Arrixaca	El Palmar
Spain	Centro Especial Ramon y Cajal	Madrid
Spain	Hospital General De Asturias	Oviedo
United Kingdom	Southmead Hospital Bristol	Bristol
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Charing Cross Hospital	London
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in SF-36v2 score after DBS (SF-10v2 in patients under the age of 18 years at the time of consent)		upto 3 years
Primary	Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score		up to 3 years
Primary	Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score		up to 3 years