Reduce tremor stiffness and slowness
- Trial ID
- NCT02071134
- Official Title
- Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
- Goal
- Reduce tremor stiffness and slowness
- Status
- RECRUITING
- Sponsor
- Boston Scientific Corporation
- Study Type
- OBSERVATIONAL
- Enrollment
- 1500 participants
- Conditions
- Parkinson's Disease
- Interventions
- Deep Brain Stimulation (DBS)
Plain-Language Summary
The goal is to gather real-world safety and outcome data on the Vercise deep brain stimulation system in people with Parkinson's, so doctors and patients can see how well the device works and how it performs over time. The Vercise system uses implanted leads to send focused electrical pulses to movement-related brain regions, such as the subthalamic nucleus or globus pallidus, to reduce tremor, stiffness, and slowness, and its directional/current-controlled stimulation aims to maximize benefit while limiting side effects, which can allow some people to reduce levodopa doses. As an observational registry, clinicians simply follow and record outcomes for people who receive the device in routine care rather than assigning treatments. Adults 18 and older who meet the local Vercise device guidelines and have no device contraindications can be enrolled; significant cognitive or psychiatric impairment may exclude someone.
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 64 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 safety and outcome data on the Vercise deep brain stimulation system in people with Parkinson's, so doctors and patients can see how well the device works and how it performs over time. The Vercise system uses implanted leads to send focused electrical pulses to movement-related brain regions, such as the subthalamic nucleus or globus pallidus, to reduce tremor, stiffness, and slowness, and its directional/current-controlled stimulation aims to maximize benefit while limiting side effects, which can allow some people to reduce levodopa doses. As an observational registry, clinicians simply follow and record outcomes for people who receive the device in routine care rather than assigning treatments. Adults 18 and older who meet the local Vercise device guidelines and have no device contraindications can be enrolled; significant cognitive or psychiatric impairment may exclude someone.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 84 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 24 years and 9 months.