Clinical trial NCT02071134: Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
Official title: Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson's Disease
Keywords: Deep brain stimulation
Parkinson's disease
Vercise
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptoms of Parkinson's disease that are not adequately controlled with medication

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.

Detailed description: 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.

Primary outcomes:
measure: Improvement in patient's quality of life (QoL) during the study as compared with baseline
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
measure: Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline
timeFrame: up to 3 years
measure: Change in medication usage during the study as compared with baseline
timeFrame: up to 3 years
measure: Impression of change scores during the study as compared with baseline
timeFrame: 3 years
Locations:
city: Aliso Viejo
country: United States
facility: Neurology and Pain Specialty
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Grand Junction
country: United States
facility: St. Mary's Hospital and Medical Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic, Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic, PA
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Boise
country: United States
facility: St. Luke Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Methodist Hospital of Indianapolis
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Great Neck
country: United States
facility: Northwell Health Neuroscience Institute
state: New York
city: Williamsville
country: United States
facility: University at Buffalo
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Medical Arts and Research Center
state: Texas
city: Sherman
country: United States
facility: Texas Institute for Neurological Disorders
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Health
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Spokane
country: United States
facility: Inland Northwest Research
state: Washington
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion Ineco-Research Facility
city: Innsbruck
country: Austria
facility: A.o. LKH Univ.-Kliniken Innsbruck
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Roeselare
country: Belgium
facility: AZ Delta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
city: Québec
country: Canada
facility: Hopital de Enfant-Jesus
city: Créteil
country: France
facility: CHU Henri Mondor
city: Lyon
country: France
facility: Hopital Neurologique Pierre Wertheimer
city: Marseille
country: France
facility: CHU La Timone Hospital
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Rennes
country: France
facility: CHRU Hopital Pontchaillou
city: Berlin
country: Germany
facility: University Berlin, Charite Virchow Standort, Wedding
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitätsklinik Eppendorf
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm-Heessen
city: Kiel
country: Germany
facility: Universitätsklinikum Campus Kiel
city: Köln
country: Germany
facility: Uniklinik Köln
city: Mainz
country: Germany
facility: Johannes Gutenberg Universitaet Mainz
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Oldenburg
country: Germany
facility: Evangelisches Krankenhaus Oldenburg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Pécs
country: Hungary
facility: Medical School of University PECS
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
city: Arcugnano
country: Italy
facility: Villa Margherita
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
city: Mestre
country: Italy
facility: Ospedale Dell Angelo
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Casimiro Mondino
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Udine
country: Italy
facility: Osp. S. Maria Della Misericordia
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul ASAN Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Bydgoszcz
country: Poland
facility: 10 Military Clinical Hospital Bydgoszcz
city: Gdańsk
country: Poland
facility: Podmiot Leczniczy Copernicus Sp. z o.o.
city: Warsaw
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital De Bellvitge
city: Madrid
country: Spain
facility: Centro Especial Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Murcia
country: Spain
facility: University Hospital Virgen Arrixaca
city: Oviedo
country: Spain
facility: Hospital General De Asturias
city: Bristol
country: United Kingdom
facility: Southmead Hospital Bristol
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Liverpool
country: United Kingdom
facility: The Walton Centre
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: London
country: United Kingdom
facility: King's College Hospital London
city: London
country: United Kingdom
facility: St. Georges Hospital
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: