RecruitingNCT02071134

Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry


Sponsor

Boston Scientific Corporation

Enrollment

1,500 participants

Start Date

Mar 4, 2014

Study Type

OBSERVATIONAL

Conditions

Summary

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. The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated. Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Meets criteria established in locally applicable Vercise System Direction for Use
  • At least 18 years old

Exclusion Criteria2

  • 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.

Interventions

DEVICEDeep Brain Stimulation (DBS)

Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their Parkinson's disease symptoms will be offered participation in this registry.


Locations(84)

Neurology and Pain Specialty

Aliso Viejo, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

University of Florida Shands Hospital

Gainesville, Florida, United States

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Tallahassee Neurological Clinic, PA

Tallahassee, Florida, United States

University of South Florida

Tampa, Florida, United States

St. Luke Regional Medical Center

Boise, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

Methodist Hospital of Indianapolis

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

St. Louis University Hospital

St Louis, Missouri, United States

Albany Medical College

Albany, New York, United States

Northwell Health Neuroscience Institute

Great Neck, New York, United States

University at Buffalo

Williamsville, New York, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Vanderbilt University

Nashville, Tennessee, United States

Houston Methodist Research Institute

Houston, Texas, United States

University of Texas Health Medical Arts and Research Center

San Antonio, Texas, United States

Texas Institute for Neurological Disorders

Sherman, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Evergreen Health

Kirkland, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

Inland Northwest Research

Spokane, Washington, United States

Fundacion Ineco-Research Facility

Buenos Aires, Argentina

A.o. LKH Univ.-Kliniken Innsbruck

Innsbruck, Austria

AZ Sint-Lucas

Ghent, Belgium

UZ Gasthuisberg

Leuven, Belgium

AZ Delta

Roeselare, Belgium

Queen Elizabeth II Health Sciences Center

Halifax, Canada

Hopital de Enfant-Jesus

Québec, Canada

CHU Henri Mondor

Créteil, France

Hopital Neurologique Pierre Wertheimer

Lyon, France

CHU La Timone Hospital

Marseille, France

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

CHRU Hopital Pontchaillou

Rennes, France

University Berlin, Charite Virchow Standort, Wedding

Berlin, Germany

Uniklinik Köln

Cologne, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsklinik Eppendorf

Hamburg, Germany

St. Barbara-Klinik Hamm-Heessen

Hamm, Germany

Universitätsklinikum Campus Kiel

Kiel, Germany

Johannes Gutenberg Universitaet Mainz

Mainz, Germany

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, Germany

Evangelisches Krankenhaus Oldenburg

Oldenburg, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Medical School of University PECS

Pécs, Hungary

Hadassah Hebrew University Medical Center

Jerusalem, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Sheba Medical Center

Tel Litwinsky, Israel

Villa Margherita

Arcugnano, Italy

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Italy

Ospedale Dell Angelo

Mestre, Italy

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Fondazione Istituto Neurologico Casimiro Mondino

Pavia, Italy

Policlinico Universitario Agostino Gemelli

Rome, Italy

Osp. S. Maria Della Misericordia

Udine, Italy

10 Military Clinical Hospital Bydgoszcz

Bydgoszcz, Poland

Podmiot Leczniczy Copernicus Sp. z o.o.

Gdansk, Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, Poland

Samsung Medical Center

Seoul, South Korea

Seoul ASAN Medical Center

Seoul, South Korea

Yonsei University Severance Hospital

Seoul, South Korea

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital De Bellvitge

Barcelona, Spain

Centro Especial Ramon y Cajal

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

University Hospital Virgen Arrixaca

Murcia, Spain

Hospital General De Asturias

Oviedo, Spain

Bahcesehir University Hospital Medical Park Goztepe

Istanbul, Turkey (Türkiye)

Koc University Hospital

Istanbul, Turkey (Türkiye)

Southmead Hospital Bristol

Bristol, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

The Walton Centre

Liverpool, United Kingdom

Charing Cross Hospital

London, United Kingdom

King's College Hospital London

London, United Kingdom

St. Georges Hospital

London, United Kingdom

Royal Victoria Infirmary

Newcastle, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom

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NCT02071134


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