Registry of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia: Vercise DBS Dystonia Registry
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02686125
Collaborator
(none)
200
33
140.8
6.1
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Registry of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia: Vercise DBS Dystonia Registry
Actual Study Start Date
:
Mar 7, 2016
Anticipated Primary Completion Date
:
Dec 1, 2027
Anticipated Study Completion Date
:
Dec 1, 2027
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score [up to 3 years]
- Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score [up to 3 years]
Other Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
7 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ Sint-Lucas | Ghent | Belgium | ||
| 2 | University Berlin, Charite Virchow Standort, Wedding | Berlin | Germany | ||
| 3 | Universitaetsklinikum Dusseldorf | Dusseldorf | Germany | ||
| 4 | Universitaetsklinikum Freiburg | Freiburg im Breisgau | Germany | ||
| 5 | Universitaetsklinik Eppendorf | Hamburg | Germany | ||
| 6 | St. Barbara-Klinik Hamm-Heessen | Hamm | Germany | ||
| 7 | Medizinische Hochschule Hannover MHH | Hannover | Germany | ||
| 8 | Universitatsklinikum Campus Kiel | Kiel | Germany | ||
| 9 | Uniklinik Köln | Köln | Germany | ||
| 10 | Johannes Gutenberg Universitaet Mainz | Mainz | Germany | ||
| 11 | Universitaetsklinikum Giessen und Marburg GmbH | Marburg | Germany | ||
| 12 | Evangelisches Krankenhaus Oldenburg | Oldenburg | Germany | ||
| 13 | Universitaetsklinikum Wuerzburg | Würzburg | Germany | ||
| 14 | Medical School of University PECS | Pecs | Hungary | ||
| 15 | Hadassah Hebrew University Medical Center | Jerusalem | Israel | ||
| 16 | Azienda Ospedaliero-Universitaria di Ferrara | Ferrara | Italy | ||
| 17 | Ospedale Dell Angelo | Mestre | Italy | ||
| 18 | Policlinico Universitario Agostino Gemelli | Rome | Italy | ||
| 19 | Osp. S. Maria Della Misericordia | Udine | Italy | ||
| 20 | St. Mary's Hospital Incheon | Incheon | Korea, Republic of | ||
| 21 | Haga Ziekenhuis locatie Leyweg | Den Haag | Netherlands | ||
| 22 | 10 Military Clinical Hospital Bydgoszcz | Bydgoszcz | Poland | ||
| 23 | Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz) | Bydgoszcz | Poland | ||
| 24 | Podmiot Leczniczy Copernicus Sp. z o.o. | Gdansk | Poland | ||
| 25 | Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie | Warsaw | Poland | ||
| 26 | National Scientific Center of Neurosurgery N.N. Burdenko | Moscow | Russian Federation | ||
| 27 | Hospital Clinic de Barcelona | Barcelona | Spain | ||
| 28 | University Hospital Virgen Arrixaca | El Palmar | Spain | ||
| 29 | Centro Especial Ramon y Cajal | Madrid | Spain | ||
| 30 | Hospital General De Asturias | Oviedo | Spain | ||
| 31 | Southmead Hospital Bristol | Bristol | United Kingdom | ||
| 32 | Queen Elizabeth University Hospital | Glasgow | United Kingdom | ||
| 33 | Royal Victoria Infirmary | Newcastle Upon Tyne | United Kingdom |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Study Director: Roshini Jain, Boston Scientific Neuromodulation Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02686125
Other Study ID Numbers:
- A4012
First Posted:
Feb 19, 2016
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022