NCT02071134

Brief 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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
151mo left

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
15 countries

84 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Mar 2014Dec 2038

First Submitted

Initial submission to the registry

February 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

March 4, 2014

Completed
24.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2038

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2038

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

24.8 years

First QC Date

February 21, 2014

Last Update Submit

June 10, 2026

Conditions

Keywords

Deep brain stimulationParkinson's diseaseVercise

Outcome Measures

Primary Outcomes (1)

  • Improvement in patient's quality of life (QoL) during the study as compared with baseline

    Change in quality of life assessments during the study as compared with baseline

    up to 3 years

Other Outcomes (3)

  • Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline

    up to 3 years

  • Change in medication usage during the study as compared with baseline

    up to 3 years

  • Impression of change scores during the study as compared with baseline

    3 years

Study Arms (1)

Parkinson's disease

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

Device: Deep Brain Stimulation (DBS)

Interventions

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

Also known as: Vercise DBS System, Boston Scientific
Parkinson's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptoms of Parkinson's disease that are not adequately controlled with medication

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (84)

Neurology and Pain Specialty

Aliso Viejo, California, 92656, United States

WITHDRAWN

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80220, United States

RECRUITING

St. Mary's Hospital and Medical Center

Grand Junction, Colorado, 81501, United States

RECRUITING

University of Florida Shands Hospital

Gainesville, Florida, 32610, United States

RECRUITING

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

WITHDRAWN

University of Miami Hospital

Miami, Florida, 33136, United States

RECRUITING

Tallahassee Neurological Clinic, PA

Tallahassee, Florida, 32308, United States

WITHDRAWN

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

St. Luke Regional Medical Center

Boise, Idaho, 83702, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Methodist Hospital of Indianapolis

Indianapolis, Indiana, 46202, United States

COMPLETED

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

WITHDRAWN

St. Louis University Hospital

St Louis, Missouri, 63110, United States

WITHDRAWN

Albany Medical College

Albany, New York, 12208, United States

COMPLETED

Northwell Health Neuroscience Institute

Great Neck, New York, 11021, United States

RECRUITING

University at Buffalo

Williamsville, New York, 14221, United States

RECRUITING

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

TERMINATED

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

WITHDRAWN

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health Medical Arts and Research Center

San Antonio, Texas, 78229, United States

RECRUITING

Texas Institute for Neurological Disorders

Sherman, Texas, 75092, United States

RECRUITING

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

WITHDRAWN

Evergreen Health

Kirkland, Washington, 98034, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Inland Northwest Research

Spokane, Washington, 99202, United States

RECRUITING

Fundacion Ineco-Research Facility

Buenos Aires, Argentina

RECRUITING

A.o. LKH Univ.-Kliniken Innsbruck

Innsbruck, Austria

RECRUITING

AZ Sint-Lucas

Ghent, Belgium

ACTIVE NOT RECRUITING

UZ Gasthuisberg

Leuven, Belgium

ACTIVE NOT RECRUITING

AZ Delta

Roeselare, Belgium

ACTIVE NOT RECRUITING

Queen Elizabeth II Health Sciences Center

Halifax, Canada

ACTIVE NOT RECRUITING

Hopital de Enfant-Jesus

Québec, Canada

ACTIVE NOT RECRUITING

CHU Henri Mondor

Créteil, France

ACTIVE NOT RECRUITING

Hopital Neurologique Pierre Wertheimer

Lyon, France

COMPLETED

CHU La Timone Hospital

Marseille, France

RECRUITING

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

TERMINATED

CHRU Hopital Pontchaillou

Rennes, France

WITHDRAWN

University Berlin, Charite Virchow Standort, Wedding

Berlin, Germany

RECRUITING

Uniklinik Köln

Cologne, Germany

COMPLETED

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

ACTIVE NOT RECRUITING

Universitätsklinik Eppendorf

Hamburg, Germany

RECRUITING

St. Barbara-Klinik Hamm-Heessen

Hamm, Germany

WITHDRAWN

Universitätsklinikum Campus Kiel

Kiel, Germany

RECRUITING

Johannes Gutenberg Universitaet Mainz

Mainz, Germany

WITHDRAWN

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, Germany

RECRUITING

Evangelisches Krankenhaus Oldenburg

Oldenburg, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Germany

RECRUITING

Medical School of University PECS

Pécs, Hungary

ACTIVE NOT RECRUITING

Hadassah Hebrew University Medical Center

Jerusalem, Israel

ACTIVE NOT RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

COMPLETED

Sheba Medical Center

Tel Litwinsky, Israel

COMPLETED

Villa Margherita

Arcugnano, Italy

TERMINATED

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Italy

COMPLETED

Ospedale Dell Angelo

Mestre, Italy

TERMINATED

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

TERMINATED

Fondazione Istituto Neurologico Casimiro Mondino

Pavia, Italy

COMPLETED

Policlinico Universitario Agostino Gemelli

Rome, Italy

RECRUITING

Osp. S. Maria Della Misericordia

Udine, Italy

TERMINATED

10 Military Clinical Hospital Bydgoszcz

Bydgoszcz, Poland

TERMINATED

Podmiot Leczniczy Copernicus Sp. z o.o.

Gdansk, Poland

COMPLETED

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, Poland

TERMINATED

Samsung Medical Center

Seoul, South Korea

ACTIVE NOT RECRUITING

Seoul ASAN Medical Center

Seoul, South Korea

TERMINATED

Yonsei University Severance Hospital

Seoul, South Korea

COMPLETED

Hospital Clinic de Barcelona

Barcelona, Spain

COMPLETED

Hospital De Bellvitge

Barcelona, Spain

ACTIVE NOT RECRUITING

Centro Especial Ramon y Cajal

Madrid, Spain

COMPLETED

Hospital Clinico San Carlos

Madrid, Spain

COMPLETED

University Hospital Virgen Arrixaca

Murcia, Spain

WITHDRAWN

Hospital General De Asturias

Oviedo, Spain

ACTIVE NOT RECRUITING

Bahcesehir University Hospital Medical Park Goztepe

Istanbul, Turkey (Türkiye)

RECRUITING

Koc University Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Southmead Hospital Bristol

Bristol, United Kingdom

COMPLETED

Queen Elizabeth University Hospital

Glasgow, United Kingdom

ACTIVE NOT RECRUITING

The Walton Centre

Liverpool, United Kingdom

COMPLETED

Charing Cross Hospital

London, United Kingdom

RECRUITING

King's College Hospital London

London, United Kingdom

COMPLETED

St. Georges Hospital

London, United Kingdom

COMPLETED

Royal Victoria Infirmary

Newcastle, United Kingdom

ACTIVE NOT RECRUITING

John Radcliffe Hospital

Oxford, United Kingdom

COMPLETED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Natalie Bloom Lyons

    Boston Scientific Neuromodulation Corporation

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2014

First Posted

February 25, 2014

Study Start

March 4, 2014

Primary Completion (Estimated)

December 1, 2038

Study Completion (Estimated)

December 1, 2038

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations