Reduce freezing of gait episodes
- Trial ID
- NCT05292794
- Official Title
- A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed With Parkinson's Disease
- Goal
- Reduce freezing of gait episodes
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- CereGate Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 41 participants
- Conditions
- Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
- Interventions
- CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
Summary For Families
Aiming to cut down freezing of gait episodes in people with Parkinson's who already have subthalamic nucleus deep brain stimulation, so walking becomes more reliable and safer. The approach loads CereGate software onto compatible Boston Scientific Gevia or Genus R16 implantable pulse generators and programmers, changing the timing and pattern of electrical pulses sent to the subthalamic nucleus (for example coordinated burst or continuous DBS modes) to better interrupt the brain circuits that trigger freezing, while being used alongside stable levodopa or dopamine agonist therapy. The trial seeks adults 21 to 80 who already have a Gevia or Genus IPG connected to FDA-approved leads, who are on stable dopaminergic medications and stable, optimized DBS settings with documented motor benefit; people who are non-ambulatory, need major walking aids, have unstable meds or DBS, or several other medical exclusions are not eligible.
Locations
- Kaiser Permanente, KPNC Comprehensive Movement Disorders Program, Redwood City, California, United States
- University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
- University of Miami, Miami, Florida, United States
- Northwestern University, Chicago, Illinois, United States
- Wake Forest University, Winston-Salem, North Carolina, United States
- Vanderbilt University Medical Center, Nashville, Tennessee, United States
- University of Washington, Seattle, Washington, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying CereGate Software; BSN cDBS Programmer; BSN Burst Programmer. Aiming to cut down freezing of gait episodes in people with Parkinson's who already have subthalamic nucleus deep brain stimulation, so walking becomes more reliable and safer. The approach loads CereGate software onto compatible Boston Scientific Gevia or Genus R16 implantable pulse generators and programmers, changing the timing and pattern of electrical pulses sent to the subthalamic nucleus (for example coordinated burst or continuous DBS modes) to better interrupt the brain circuits that trigger freezing, while being used alongside stable levodopa or dopamine agonist therapy. The trial seeks adults 21 to 80 who already have a Gevia or Genus IPG connected to FDA-approved leads, who are on stable dopaminergic medications and stable, optimized DBS settings with documented motor benefit; people who are non-ambulatory, need major walking aids, have unstable meds or DBS, or several other medical exclusions are not eligible.
- Who can participate?
- Participants must be between 21 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 7 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 5 years and 1 month.
- 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.