Observing outcomes of Vercise DBS for treating dystonia
Prospective Study of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia
Boston Scientific Corporation · NCT02686125
This study looks at how well the Vercise Deep Brain Stimulation system helps people with dystonia feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation (industry) |
| Locations | 36 sites (Ghent and 35 other locations) |
| Trial ID | NCT02686125 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the effectiveness of the Vercise™ Deep Brain Stimulation (DBS) Systems developed by Boston Scientific Corporation for patients with dystonia. It will assess improvements in disease symptoms and overall quality of life among participants. The study will include individuals who meet specific eligibility criteria related to the use of the Vercise System. Data collected will help understand the system's impact on patients in a practical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 7 years and older who meet the criteria for the Vercise System's use in treating dystonia.
Not a fit: Patients who have contraindications as per the Vercise System's Directions for Use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of DBS in improving symptoms and quality of life for patients with dystonia.
How similar studies have performed: Other studies have shown positive outcomes with deep brain stimulation for movement disorders, suggesting this approach has a foundation of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ghent and 35 other locations
- AZ Sint-Lucas — Ghent, Belgium (TERMINATED)
- UZ Gasthuisberg — Leuven, Belgium (RECRUITING)
- Queen Elizabeth II Health Sciences Center — Halifax, Canada (RECRUITING)
- University Berlin, Charite Virchow Standort, Wedding — Berlin, Germany (RECRUITING)
- Uniklinik Köln — Cologne, Germany (RECRUITING)
- Universitaetsklinikum Dusseldorf — Düsseldorf, Germany (RECRUITING)
- Universitaetsklinikum Freiburg — Freiburg im Breisgau, Germany (RECRUITING)
- Universitaetsklinik Eppendorf — Hamburg, Germany (RECRUITING)
- St. Barbara-Klinik Hamm-Heessen — Hamm, Germany (COMPLETED)
- Medizinische Hochschule Hannover MHH — Hanover, Germany (RECRUITING)
- Universitatsklinikum Campus Kiel — Kiel, Germany (RECRUITING)
- Johannes Gutenberg Universitaet Mainz — Mainz, Germany (TERMINATED)
- Universitaetsklinikum Giessen und Marburg GmbH — Marburg, Germany (RECRUITING)
- Evangelisches Krankenhaus Oldenburg — Oldenburg, Germany (WITHDRAWN)
- Universitaetsklinikum Wuerzburg — Würzburg, Germany (RECRUITING)
- Medical School of University PECS — Pécs, Hungary (RECRUITING)
- Hadassah Hebrew University Medical Center — Jerusalem, Israel (COMPLETED)
- Azienda Ospedaliero-Universitaria di Ferrara — Ferrara, Italy (COMPLETED)
- Ospedale Dell Angelo — Mestre, Italy (RECRUITING)
- Policlinico Universitario Agostino Gemelli — Rome, Italy (COMPLETED)
- Osp. S. Maria Della Misericordia — Udine, Italy (TERMINATED)
- Haga Ziekenhuis locatie Leyweg — The Hague, Netherlands (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, Russia (TERMINATED)
- St. Mary's Hospital Incheon — Incheon, South Korea (ACTIVE_NOT_RECRUITING)
- Hospital Clinic de Barcelona — Barcelona, Spain (COMPLETED)
- University Hospital Virgen Arrixaca — El Palmar, Spain (WITHDRAWN)
- Centro Especial Ramon y Cajal — Madrid, Spain (COMPLETED)
- Hospital General De Asturias — Oviedo, Spain (WITHDRAWN)
- Southmead Hospital Bristol — Bristol, United Kingdom (WITHDRAWN)
- Queen Elizabeth University Hospital — Glasgow, United Kingdom (COMPLETED)
- Charing Cross Hospital — London, United Kingdom (RECRUITING)
- Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Stephanie Delvaux
- Email: BSNClinicalTrials@bsci.com
- Phone: 855-213-9890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dystonia