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Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
NCT02071134 · Boston Scientific Corporation
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.
Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Image Guided Programming (IGP) when used as a planning tool for programming of patients is also evaluated.
Eligibility criteria
Key Inclusion Criteria:
* Meets criteria established in locally applicable Vercise System Direction for Use
* At least 18 years old
Key Exclusion Criteria:
* Meets any contraindication in the Vercise System locally applicable Directions for Use
Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.
Study design
Enrollment target: 1500 participants
Age groups: adult, older_adult
Timeline
Starts: 2014-03-04
Estimated completion: 2038-12
Last updated: 2026-04-13
Interventions
Device: Deep Brain Stimulation (DBS)
Primary outcomes
- • Improvement in patient's quality of life (QoL) during the study as compared with baseline (up to 3 years)
Sponsor
Boston Scientific Corporation · industry
Contacts & investigators
ContactHeleen Scholtes · contact · BSNClinicalTrials@bsci.com · 855-213-9890
ContactAlison Lewis · contact · BSNClinicalTrials@bsci.com · 855-213-9890
InvestigatorNatalie Bloom Lyons · study_director, Boston Scientific Neuromodulation Corporation
All locations (84)
Neurology and Pain SpecialtyWithdrawn
Aliso Viejo, California, United States
Cedars Sinai Medical CenterRecruiting
Los Angeles, California, United States
University of ColoradoRecruiting
Aurora, Colorado, United States
St. Mary's Hospital and Medical CenterRecruiting
Grand Junction, Colorado, United States
University of Florida Shands HospitalRecruiting
Gainesville, Florida, United States
Mayo Clinic, JacksonvilleWithdrawn
Jacksonville, Florida, United States
University of Miami HospitalRecruiting
Miami, Florida, United States
Tallahassee Neurological Clinic, PAWithdrawn
Tallahassee, Florida, United States
University of South FloridaRecruiting
Tampa, Florida, United States
St. Luke Regional Medical CenterRecruiting
Boise, Idaho, United States
Rush University Medical CenterRecruiting
Chicago, Illinois, United States
Methodist Hospital of IndianapolisRecruiting
Indianapolis, Indiana, United States
Massachusetts General HospitalWithdrawn
Boston, Massachusetts, United States
St. Louis University HospitalWithdrawn
St Louis, Missouri, United States
Albany Medical CollegeRecruiting
Albany, New York, United States
Northwell Health Neuroscience InstituteRecruiting
Great Neck, New York, United States
University at BuffaloRecruiting
Williamsville, New York, United States
Wake Forest University School of MedicineRecruiting
Winston-Salem, North Carolina, United States
Cleveland Clinic FoundationTerminated
Cleveland, Ohio, United States
Ohio State UniversityRecruiting
Columbus, Ohio, United States
Vanderbilt UniversityWithdrawn
Nashville, Tennessee, United States
Houston Methodist Research InstituteRecruiting
Houston, Texas, United States
University of Texas Health Medical Arts and Research CenterRecruiting
San Antonio, Texas, United States
Texas Institute for Neurological DisordersRecruiting
Sherman, Texas, United States
University of Virginia Medical CenterWithdrawn
Charlottesville, Virginia, United States
Evergreen HealthRecruiting
Kirkland, Washington, United States
University of Washington Medical CenterRecruiting
Seattle, Washington, United States
Inland Northwest ResearchRecruiting
Spokane, Washington, United States
Fundacion Ineco-Research FacilityActive Not Recruiting
Buenos Aires, Argentina
A.o. LKH Univ.-Kliniken InnsbruckRecruiting
Innsbruck, Austria
AZ Sint-LucasRecruiting
Ghent, Belgium
UZ GasthuisbergRecruiting
Leuven, Belgium
AZ DeltaRecruiting
Roeselare, Belgium
Queen Elizabeth II Health Sciences CenterActive Not Recruiting
Halifax, Canada
Hopital de Enfant-JesusActive Not Recruiting
Québec, Canada
CHU Henri MondorActive Not Recruiting
Créteil, France
Hopital Neurologique Pierre WertheimerCompleted
Lyon, France
CHU La Timone HospitalRecruiting
Marseille, France
Fondation Ophtalmologique Adolphe de RothschildTerminated
Paris, France
CHRU Hopital PontchaillouWithdrawn
Rennes, France
University Berlin, Charite Virchow Standort, WeddingRecruiting
Berlin, Germany
Uniklinik KölnCompleted
Cologne, Germany
Universitätsklinikum DüsseldorfRecruiting
Düsseldorf, Germany
Universitätsklinikum FreiburgActive Not Recruiting
Freiburg im Breisgau, Germany
Universitätsklinik EppendorfRecruiting
Hamburg, Germany
St. Barbara-Klinik Hamm-HeessenWithdrawn
Hamm, Germany
Universitätsklinikum Campus KielActive Not Recruiting
Kiel, Germany
Johannes Gutenberg Universitaet MainzWithdrawn
Mainz, Germany
Universitaetsklinikum Giessen und Marburg GmbHRecruiting
Marburg, Germany
Evangelisches Krankenhaus OldenburgRecruiting
Oldenburg, Germany
Universitätsklinikum WürzburgRecruiting
Würzburg, Germany
Medical School of University PECSActive Not Recruiting
Pécs, Hungary
Hadassah Hebrew University Medical CenterActive Not Recruiting
Jerusalem, Israel
Tel Aviv Sourasky Medical CenterCompleted
Tel Aviv, Israel
Sheba Medical CenterCompleted
Tel Litwinsky, Israel
Villa MargheritaTerminated
Arcugnano, Italy
Azienda Ospedaliero-Universitaria di FerraraCompleted
Ferrara, Italy
Ospedale Dell AngeloTerminated
Mestre, Italy
IRCCS Istituto Ortopedico GaleazziTerminated
Milan, Italy
Fondazione Istituto Neurologico Casimiro MondinoCompleted
Pavia, Italy
Policlinico Universitario Agostino GemelliRecruiting
Rome, Italy
Osp. S. Maria Della MisericordiaTerminated
Udine, Italy
10 Military Clinical Hospital BydgoszczTerminated
Bydgoszcz, Poland
Podmiot Leczniczy Copernicus Sp. z o.o.Completed
Gdansk, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-CurieTerminated
Warsaw, Poland
Samsung Medical CenterRecruiting
Seoul, South Korea
Seoul ASAN Medical CenterTerminated
Seoul, South Korea
Yonsei University Severance HospitalCompleted
Seoul, South Korea
Hospital Clinic de BarcelonaActive Not Recruiting
Barcelona, Spain
Hospital De BellvitgeActive Not Recruiting
Barcelona, Spain
Centro Especial Ramon y CajalCompleted
Madrid, Spain
Hospital Clinico San CarlosCompleted
Madrid, Spain
University Hospital Virgen ArrixacaWithdrawn
Murcia, Spain
Hospital General De AsturiasActive Not Recruiting
Oviedo, Spain
Bahcesehir University Hospital Medical Park GoztepeRecruiting
Istanbul, Turkey (Türkiye)
Koc University HospitalRecruiting
Istanbul, Turkey (Türkiye)
Southmead Hospital BristolCompleted
Bristol, United Kingdom
Queen Elizabeth University HospitalActive Not Recruiting
Glasgow, United Kingdom
The Walton CentreCompleted
Liverpool, United Kingdom
Charing Cross HospitalActive Not Recruiting
London, United Kingdom
King's College Hospital LondonCompleted
London, United Kingdom
St. Georges HospitalCompleted
London, United Kingdom
Royal Victoria InfirmaryActive Not Recruiting
Newcastle, United Kingdom
John Radcliffe HospitalCompleted
Oxford, United Kingdom