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
Plain-Language Summary
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.