Registry of outcomes for the Vercise DBS System in Parkinson's disease
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
This study is collecting information from around the world to see how well the Vercise Deep Brain Stimulation system helps people with Parkinson's disease manage their symptoms and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 84 sites (Aliso Viejo, California and 83 other locations) |
| Trial ID | NCT02071134 on ClinicalTrials.gov |
What this trial studies
This registry aims to compile worldwide outcomes from the use of the Vercise Deep Brain Stimulation (DBS) System by Boston Scientific in treating Parkinson's disease. It evaluates the effectiveness of the system in improving disease symptoms and overall quality of life, comparing results to baseline measurements. The study also assesses the use of Image Guided Programming (IGP) and the DBS Illumina 3D feature as planning tools for patient programming. By gathering data from various locations, the registry seeks to provide a comprehensive overview of the system's performance.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who meet the criteria for the Vercise System's use.
Not a fit: Patients with significant cognitive or psychiatric impairments or those who meet contraindications for the Vercise System may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of Vercise DBS System's effectiveness, leading to improved treatment strategies for Parkinson's disease patients.
How similar studies have performed: Other studies on deep brain stimulation have shown promising results, indicating that this approach is supported by prior successful outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aliso Viejo, California and 83 other locations
- Neurology and Pain Specialty — Aliso Viejo, California, United States (Withdrawn)
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States (Recruiting)
- University of Florida Shands Hospital — Gainesville, Florida, United States (Recruiting)
- Mayo Clinic, Jacksonville — Jacksonville, Florida, United States (Withdrawn)
- University of Miami Hospital — Miami, Florida, United States (Recruiting)
- Tallahassee Neurological Clinic, PA — Tallahassee, Florida, United States (Withdrawn)
- University of South Florida — Tampa, Florida, United States (Recruiting)
- St. Luke Regional Medical Center — Boise, Idaho, United States (Recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- Methodist Hospital of Indianapolis — Indianapolis, Indiana, United States (Completed)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Withdrawn)
- St. Louis University Hospital — St Louis, Missouri, United States (Withdrawn)
- Albany Medical College — Albany, New York, United States (Completed)
- Northwell Health Neuroscience Institute — Great Neck, New York, United States (Recruiting)
- University at Buffalo — Williamsville, New York, United States (Recruiting)
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Terminated)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Vanderbilt University — Nashville, Tennessee, United States (Withdrawn)
- Houston Methodist Research Institute — Houston, Texas, United States (Recruiting)
- University of Texas Health Medical Arts and Research Center — San Antonio, Texas, United States (Recruiting)
- Texas Institute for Neurological Disorders — Sherman, Texas, United States (Recruiting)
- University of Virginia Medical Center — Charlottesville, Virginia, United States (Withdrawn)
- Evergreen Health — Kirkland, Washington, United States (Recruiting)
- University of Washington Medical Center — Seattle, Washington, United States (Recruiting)
- Inland Northwest Research — Spokane, Washington, United States (Recruiting)
- Fundacion Ineco-Research Facility — Buenos Aires, Argentina (Active_not_recruiting)
- A.o. LKH Univ.-Kliniken Innsbruck — Innsbruck, Austria (Recruiting)
- AZ Sint-Lucas — Ghent, Belgium (Recruiting)
- UZ Gasthuisberg — Leuven, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (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 (Active_not_recruiting)
- Johannes Gutenberg Universitaet Mainz — Mainz, Germany (Withdrawn)
- Universitaetsklinikum Giessen und Marburg GmbH — Marburg, Germany (Recruiting)
- Evangelisches Krankenhaus Oldenburg — Oldenburg, Germany (Recruiting)
+34 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Heleen Scholtes
- Email: BSNClinicalTrials@bsci.com
- Phone: 855-213-9890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.