Deep Brain Stimulation for Parkinson's (NCT02071134)
Brain stimulation improves daily movement
- Trial ID
- NCT02071134
- Official Title
- Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
- Goal
- Brain stimulation improves daily movement
- Status
- RECRUITING
- Sponsor
- Boston Scientific Corporation
- Study Type
- OBSERVATIONAL
- Enrollment
- 1500 participants
- Conditions
- Parkinson's Disease
- Interventions
- Deep Brain Stimulation (DBS)
Summary For Families
The goal is to gather real-world outcomes from using Boston Scientific's Vercise deep brain stimulation system for Parkinson's, tracking changes in symptoms and overall quality of life compared with each person’s baseline. The study follows people treated with the commercially available Vercise system and looks at how clinicians use planning tools, like Image Guided Programming and the Illumina 3D programming feature, to set up and adjust the device. It is a worldwide registry of treated patients rather than a drug trial, collecting how the device is used and how people do afterward. Adults 18 and older who meet their local directions for use of the Vercise system can enroll, while anyone with contraindications in those local directions or major cognitive or psychiatric problems may be excluded.
Locations
- Neurology and Pain Specialty, Aliso Viejo, California, United States
- Cedars Sinai Medical Center, Los Angeles, California, United States
- University of Colorado, Aurora, Colorado, United States
- St. Mary's Hospital and Medical Center, Grand Junction, Colorado, United States
- University of Florida Shands Hospital, Gainesville, Florida, United States
- Mayo Clinic, Jacksonville, Jacksonville, Florida, United States
- University of Miami Hospital, Miami, Florida, United States
- Tallahassee Neurological Clinic, PA, Tallahassee, Florida, United States
- University of South Florida, Tampa, Florida, United States
- St. Luke Regional Medical Center, Boise, Idaho, United States
- Rush University Medical Center, Chicago, Illinois, United States
- Methodist Hospital of Indianapolis, Indianapolis, Indiana, United States
- Massachusetts General Hospital, Boston, Massachusetts, United States
- St. Louis University Hospital, St Louis, Missouri, United States
- Albany Medical College, Albany, New York, United States
- Northwell Health Neuroscience Institute, Great Neck, New York, United States
- University at Buffalo, Williamsville, New York, United States
- Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
- Cleveland Clinic Foundation, Cleveland, Ohio, United States
- Ohio State University, Columbus, Ohio, United States
And 65 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep Brain Stimulation (DBS). The goal is to gather real-world outcomes from using Boston Scientific's Vercise deep brain stimulation system for Parkinson's, tracking changes in symptoms and overall quality of life compared with each person’s baseline. The study follows people treated with the commercially available Vercise system and looks at how clinicians use planning tools, like Image Guided Programming and the Illumina 3D programming feature, to set up and adjust the device. It is a worldwide registry of treated patients rather than a drug trial, collecting how the device is used and how people do afterward. Adults 18 and older who meet their local directions for use of the Vercise system can enroll, while anyone with contraindications in those local directions or major cognitive or psychiatric problems may be excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 85 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 24 years and 9 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.