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)
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.