CereGate Software; BSN cDBS Progra… for Parkinson's (NCT05292794)
Reduce freezing episodes while walking
- 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 episodes while walking
- 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
Goal: See if CereGate therapy can reduce freezing of gait, the sudden brief inability to step, in people with Parkinson's who already have a deep brain stimulation implant in the subthalamic nucleus. Approach: CereGate is a software-based therapy used with the person’s existing deep brain stimulation implant and special programmers, and participants are assessed before starting CereGate and again while using it; there is no random assignment. Eligibility: Adults 21 to 80 who have a compatible Boston Scientific Gevia or Genus implant connected to approved leads, are on Parkinson's medications such as carbidopa/levodopa or a dopamine agonist at stable, optimal doses, and whose deep brain stimulation has already shown improvement in movement; medications and stimulation settings must have been stable for at least 28 days. Logistics: Participation includes five visits over about 104 days.
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. Goal: See if CereGate therapy can reduce freezing of gait, the sudden brief inability to step, in people with Parkinson's who already have a deep brain stimulation implant in the subthalamic nucleus. Approach: CereGate is a software-based therapy used with the person’s existing deep brain stimulation implant and special programmers, and participants are assessed before starting CereGate and again while using it; there is no random assignment. Eligibility: Adults 21 to 80 who have a compatible Boston Scientific Gevia or Genus implant connected to approved leads, are on Parkinson's medications such as carbidopa/levodopa or a dopamine agonist at stable, optimal doses, and whose deep brain stimulation has already shown improvement in movement; medications and stimulation settings must have been stable for at least 28 days. Logistics: Participation includes five visits over about 104 days.
- 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?
- 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 5 years and 1 month.
- 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- Participants will complete a total of five study visits over up to 104 days.
- 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.