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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02071134
• Other study ID #: A4010
• Secondary ID: A4069
• Status: Recruiting
• Start date: March 4, 2014
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Heleen Scholtes
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Argentina	Fundacion Ineco-Research Facility	Ciudad Autonoma de Buenos Aires
Austria	A.o. LKH Univ.-Kliniken Innsbruck	Innsbruck
Belgium	AZ Sint-Lucas	Gent
Belgium	UZ Gasthuisberg	Leuven
Belgium	AZ Delta	Roeselare
Canada	Queen Elizabeth II Health Sciences Center	Halifax
Canada	Hopital de Enfant-Jesus	Québec
France	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
Germany	University Berlin, Charite Virchow Standort, Wedding	Berlin
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Universitätsklinik Eppendorf	Hamburg
Germany	St. Barbara-Klinik Hamm-Heessen	Hamm
Germany	Universitätsklinikum Campus Kiel	Kiel
Germany	Uniklinik Köln	Köln
Germany	Johannes Gutenberg Universitaet Mainz	Mainz
Germany	Universitaetsklinikum Giessen und Marburg GmbH	Marburg
Germany	Evangelisches Krankenhaus Oldenburg	Oldenburg
Germany	Universitätsklinikum Würzburg	Würzburg
Hungary	Medical School of University PECS	Pécs
Israel	Hadassah Hebrew University Medical Center	Jerusalem
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Sheba Medical Center	Tel HaShomer
Italy	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
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul ASAN Medical Center	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Poland	10 Military Clinical Hospital Bydgoszcz	Bydgoszcz
Poland	Podmiot Leczniczy Copernicus Sp. z o.o.	Gdansk
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie	Warsaw
Spain	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
United Kingdom	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 States	Albany Medical College	Albany	New York
United States	Neurology and Pain Specialty	Aliso Viejo	California
United States	University of Colorado	Aurora	Colorado
United States	St. Luke Regional Medical Center	Boise	Idaho
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Florida Shands Hospital	Gainesville	Florida
United States	St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	Northwell Health Neuroscience Institute	Great Neck	New York
United States	Methodist Hospital of Indianapolis	Indianapolis	Indiana
United States	Mayo Clinic, Jacksonville	Jacksonville	Florida
United States	Evergreen Health	Kirkland	Washington
United States	University of Miami Hospital	Miami	Florida
United States	Vanderbilt University	Nashville	Tennessee
United States	St. Louis University Hospital	Saint Louis	Missouri
United States	University of Texas Health Medical Arts and Research Center	San Antonio	Texas
United States	University of Washington Medical Center	Seattle	Washington
United States	Texas Institute for Neurological Disorders	Sherman	Texas
United States	Inland Northwest Research	Spokane	Washington
United States	Tallahassee Neurological Clinic, PA	Tallahassee	Florida
United States	University of South Florida	Tampa	Florida
United States	University at Buffalo	Williamsville	New York
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Canada,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline	Change in patient's motor symptoms as determined by UPDRS during the study as compared with baseline	up to 3 years
Other	Change in medication usage during the study as compared with baseline		up to 3 years
Other	Impression of change scores during the study as compared with baseline	Impression of change scores during the study as compared with baseline	3 years
Primary	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