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

NCT ID: NCT02071134

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-04

Study Completion Date

2038-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson's disease

Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.

Deep Brain Stimulation (DBS)

Intervention Type DEVICE

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

Interventions

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Deep 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.

Intervention Type DEVICE

Other Intervention Names

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Vercise DBS System Boston Scientific

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Bloom Lyons

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

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Neurology and Pain Specialty

Aliso Viejo, California, United States

Site Status WITHDRAWN

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

University of Colorado

Aurora, Colorado, United States

Site Status RECRUITING

St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status RECRUITING

University of Florida Shands Hospital

Gainesville, Florida, United States

Site Status RECRUITING

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

Site Status WITHDRAWN

University of Miami Hospital

Miami, Florida, United States

Site Status RECRUITING

Tallahassee Neurological Clinic, PA

Tallahassee, Florida, United States

Site Status WITHDRAWN

University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

St. Luke Regional Medical Center

Boise, Idaho, United States

Site Status RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Methodist Hospital of Indianapolis

Indianapolis, Indiana, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status WITHDRAWN

St. Louis University Hospital

St Louis, Missouri, United States

Site Status WITHDRAWN

Albany Medical College

Albany, New York, United States

Site Status RECRUITING

Northwell Health Neuroscience Institute

Great Neck, New York, United States

Site Status RECRUITING

University at Buffalo

Williamsville, New York, United States

Site Status RECRUITING

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status TERMINATED

Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Vanderbilt University

Nashville, Tennessee, United States

Site Status WITHDRAWN

Houston Methodist Research Institute

Houston, Texas, United States

Site Status RECRUITING

University of Texas Health Medical Arts and Research Center

San Antonio, Texas, United States

Site Status RECRUITING

Texas Institute for Neurological Disorders

Sherman, Texas, United States

Site Status RECRUITING

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status WITHDRAWN

Evergreen Health

Kirkland, Washington, United States

Site Status RECRUITING

University of Washington Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Inland Northwest Research

Spokane, Washington, United States

Site Status RECRUITING

Fundacion Ineco-Research Facility

Buenos Aires, , Argentina

Site Status ACTIVE_NOT_RECRUITING

A.o. LKH Univ.-Kliniken Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

AZ Sint-Lucas

Ghent, , Belgium

Site Status RECRUITING

UZ Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Queen Elizabeth II Health Sciences Center

Halifax, , Canada

Site Status ACTIVE_NOT_RECRUITING

Hopital de Enfant-Jesus

Québec, , Canada

Site Status ACTIVE_NOT_RECRUITING

CHU Henri Mondor

Créteil, , France

Site Status ACTIVE_NOT_RECRUITING

Hopital Neurologique Pierre Wertheimer

Lyon, , France

Site Status COMPLETED

CHU La Timone Hospital

Marseille, , France

Site Status RECRUITING

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status TERMINATED

CHRU Hopital Pontchaillou

Rennes, , France

Site Status WITHDRAWN

University Berlin, Charite Virchow Standort, Wedding

Berlin, , Germany

Site Status RECRUITING

Uniklinik Köln

Cologne, , Germany

Site Status COMPLETED

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinik Eppendorf

Hamburg, , Germany

Site Status RECRUITING

St. Barbara-Klinik Hamm-Heessen

Hamm, , Germany

Site Status WITHDRAWN

Universitätsklinikum Campus Kiel

Kiel, , Germany

Site Status ACTIVE_NOT_RECRUITING

Johannes Gutenberg Universitaet Mainz

Mainz, , Germany

Site Status WITHDRAWN

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Oldenburg

Oldenburg, , Germany

Site Status RECRUITING

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status RECRUITING

Medical School of University PECS

Pécs, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Hadassah Hebrew University Medical Center

Jerusalem, , Israel

Site Status ACTIVE_NOT_RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status COMPLETED

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status COMPLETED

Villa Margherita

Arcugnano, , Italy

Site Status TERMINATED

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, , Italy

Site Status COMPLETED

Ospedale Dell Angelo

Mestre, , Italy

Site Status TERMINATED

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status TERMINATED

Fondazione Istituto Neurologico Casimiro Mondino

Pavia, , Italy

Site Status COMPLETED

Policlinico Universitario Agostino Gemelli

Rome, , Italy

Site Status RECRUITING

Osp. S. Maria Della Misericordia

Udine, , Italy

Site Status TERMINATED

10 Military Clinical Hospital Bydgoszcz

Bydgoszcz, , Poland

Site Status TERMINATED

Podmiot Leczniczy Copernicus Sp. z o.o.

Gdansk, , Poland

Site Status COMPLETED

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, , Poland

Site Status TERMINATED

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Seoul ASAN Medical Center

Seoul, , South Korea

Site Status TERMINATED

Yonsei University Severance Hospital

Seoul, , South Korea

Site Status COMPLETED

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital De Bellvitge

Barcelona, , Spain

Site Status ACTIVE_NOT_RECRUITING

Centro Especial Ramon y Cajal

Madrid, , Spain

Site Status COMPLETED

Hospital Clinico San Carlos

Madrid, , Spain

Site Status COMPLETED

University Hospital Virgen Arrixaca

Murcia, , Spain

Site Status WITHDRAWN

Hospital General De Asturias

Oviedo, , Spain

Site Status ACTIVE_NOT_RECRUITING

Bahcesehir University Hospital Medical Park Goztepe

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Koc University Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Southmead Hospital Bristol

Bristol, , United Kingdom

Site Status COMPLETED

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

The Walton Centre

Liverpool, , United Kingdom

Site Status COMPLETED

Charing Cross Hospital

London, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

King's College Hospital London

London, , United Kingdom

Site Status COMPLETED

St. Georges Hospital

London, , United Kingdom

Site Status COMPLETED

Royal Victoria Infirmary

Newcastle, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status COMPLETED

Countries

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United States Argentina Austria Belgium Canada France Germany Hungary Israel Italy Poland South Korea Spain Turkey (Türkiye) United Kingdom

Central Contacts

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Heleen Scholtes

Role: CONTACT

855-213-9890

Alison Lewis

Role: CONTACT

855-213-9890

Facility Contacts

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Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Other Identifiers

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A4069

Identifier Type: OTHER

Identifier Source: secondary_id

A4010

Identifier Type: -

Identifier Source: org_study_id

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