Registry of Deep Brain Stimulation With the VERCISEโข System: Vercise DBS Registry
- Conditions
- Parkinson's Disease
- Interventions
- Device: Deep Brain Stimulation (DBS)
- Registration Number
- NCT02071134
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Meets criteria established in locally applicable Vercise System Direction for Use
- At least 18 years old
Key
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parkinson's disease Deep Brain Stimulation (DBS) Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.
- Primary Outcome Measures
Name Time Method Improvement in patient's quality of life (QoL) during the study as compared with baseline up to 3 years Change in quality of life assessments during the study as compared with baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (81)
Neurology and Pain Specialty
๐บ๐ธAliso Viejo, California, United States
University of Colorado
๐บ๐ธAurora, Colorado, United States
St. Mary's Hospital and Medical Center
๐บ๐ธGrand Junction, Colorado, United States
University of Florida Shands Hospital
๐บ๐ธGainesville, Florida, United States
Mayo Clinic, Jacksonville
๐บ๐ธJacksonville, Florida, United States
University of Miami Hospital
๐บ๐ธMiami, Florida, United States
Tallahassee Neurological Clinic, PA
๐บ๐ธTallahassee, Florida, United States
University of South Florida
๐บ๐ธTampa, Florida, United States
St. Luke Regional Medical Center
๐บ๐ธBoise, Idaho, United States
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
Methodist Hospital of Indianapolis
๐บ๐ธIndianapolis, Indiana, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
St. Louis University Hospital
๐บ๐ธSaint Louis, Missouri, United States
Albany Medical College
๐บ๐ธAlbany, New York, United States
Northwell Health Neuroscience Institute
๐บ๐ธGreat Neck, New York, United States
University at Buffalo
๐บ๐ธWilliamsville, New York, United States
Wake Forest University School of Medicine
๐บ๐ธWinston-Salem, North Carolina, United States
Cleveland Clinic Foundation
๐บ๐ธCleveland, Ohio, United States
Ohio State University
๐บ๐ธColumbus, Ohio, United States
Vanderbilt University
๐บ๐ธNashville, Tennessee, United States
Houston Methodist Research Institute
๐บ๐ธHouston, Texas, United States
University of Texas Health Medical Arts and Research Center
๐บ๐ธSan Antonio, Texas, United States
Texas Institute for Neurological Disorders
๐บ๐ธSherman, Texas, United States
University of Virginia Medical Center
๐บ๐ธCharlottesville, Virginia, United States
Evergreen Health
๐บ๐ธKirkland, Washington, United States
University of Washington Medical Center
๐บ๐ธSeattle, Washington, United States
Inland Northwest Research
๐บ๐ธSpokane, Washington, United States
Fundacion Ineco-Research Facility
๐ฆ๐ทCiudad Autonoma de Buenos Aires, Argentina
A.o. LKH Univ.-Kliniken Innsbruck
๐ฆ๐นInnsbruck, Austria
AZ Sint-Lucas
๐ง๐ชGent, Belgium
UZ Gasthuisberg
๐ง๐ชLeuven, Belgium
AZ Delta
๐ง๐ชRoeselare, Belgium
Queen Elizabeth II Health Sciences Center
๐จ๐ฆHalifax, Canada
Hopital de Enfant-Jesus
๐จ๐ฆQuรฉbec, Canada
CHU Henri Mondor
๐ซ๐ทCrรฉteil, France
Hopital Neurologique Pierre Wertheimer
๐ซ๐ทLyon, France
CHU La Timone Hospital
๐ซ๐ทMarseille, France
Fondation Ophtalmologique Adolphe de Rothschild
๐ซ๐ทParis, France
CHRU Hopital Pontchaillou
๐ซ๐ทRennes, France
University Berlin, Charite Virchow Standort, Wedding
๐ฉ๐ชBerlin, Germany
Universitรคtsklinikum Dรผsseldorf
๐ฉ๐ชDรผsseldorf, Germany
Universitรคtsklinikum Freiburg
๐ฉ๐ชFreiburg, Germany
Universitรคtsklinik Eppendorf
๐ฉ๐ชHamburg, Germany
St. Barbara-Klinik Hamm-Heessen
๐ฉ๐ชHamm, Germany
Universitรคtsklinikum Campus Kiel
๐ฉ๐ชKiel, Germany
Uniklinik Kรถln
๐ฉ๐ชKรถln, Germany
Johannes Gutenberg Universitaet Mainz
๐ฉ๐ชMainz, Germany
Universitaetsklinikum Giessen und Marburg GmbH
๐ฉ๐ชMarburg, Germany
Evangelisches Krankenhaus Oldenburg
๐ฉ๐ชOldenburg, Germany
Universitรคtsklinikum Wรผrzburg
๐ฉ๐ชWรผrzburg, Germany
Medical School of University PECS
๐ญ๐บPรฉcs, Hungary
Hadassah Hebrew University Medical Center
๐ฎ๐ฑJerusalem, Israel
Tel Aviv Sourasky Medical Center
๐ฎ๐ฑTel Aviv, Israel
Sheba Medical Center
๐ฎ๐ฑTel HaShomer, Israel
Villa Margherita
๐ฎ๐นArcugnano, Italy
Azienda Ospedaliero-Universitaria di Ferrara
๐ฎ๐นFerrara, Italy
Ospedale Dell Angelo
๐ฎ๐นMestre, Italy
IRCCS Istituto Ortopedico Galeazzi
๐ฎ๐นMilan, Italy
Fondazione Istituto Neurologico Casimiro Mondino
๐ฎ๐นPavia, Italy
Policlinico Universitario Agostino Gemelli
๐ฎ๐นRome, Italy
Osp. S. Maria Della Misericordia
๐ฎ๐นUdine, Italy
Samsung Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Seoul ASAN Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Yonsei University Severance Hospital
๐ฐ๐ทSeoul, Korea, Republic of
10 Military Clinical Hospital Bydgoszcz
๐ต๐ฑBydgoszcz, Poland
Podmiot Leczniczy Copernicus Sp. z o.o.
๐ต๐ฑGdaลsk, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
๐ต๐ฑWarsaw, Poland
Hospital Clinic de Barcelona
๐ช๐ธBarcelona, Spain
Hospital De Bellvitge
๐ช๐ธBarcelona, Spain
Centro Especial Ramon y Cajal
๐ช๐ธMadrid, Spain
Hospital Clinico San Carlos
๐ช๐ธMadrid, Spain
University Hospital Virgen Arrixaca
๐ช๐ธMurcia, Spain
Hospital General De Asturias
๐ช๐ธOviedo, Spain
Southmead Hospital Bristol
๐ฌ๐งBristol, United Kingdom
Queen Elizabeth University Hospital
๐ฌ๐งGlasgow, United Kingdom
The Walton Centre
๐ฌ๐งLiverpool, United Kingdom
Charing Cross Hospital
๐ฌ๐งLondon, United Kingdom
King's College Hospital London
๐ฌ๐งLondon, United Kingdom
St. Georges Hospital
๐ฌ๐งLondon, United Kingdom
Royal Victoria Infirmary
๐ฌ๐งNewcastle, United Kingdom
John Radcliffe Hospital
๐ฌ๐งOxford, United Kingdom