Use of CereGate Therapy for Freezing of Gait in PD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorCereGate Inc.
About this trial
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.
Eligibility criteria
Qualifiers
Participant has an implanted STN-DBS system with Boston Scientific Gevia™ or Genus™ R16 IPG connected to any brand lead or extension that have been approved by the FDA to be used with Gevia or Genus IPGs.
Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist.
DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS
Disqualifiers
Participant is unable to understand the study requirements and the treatment procedures, or unwilling / unable to provide written informed consent before any study-specific tests or procedures are performed.
Participant is unwilling or unable to comply with visit schedule and study related procedures.
Participant's medication regimen has not been stable for at least 28 days prior to CG initiation.
Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation.
Trial design
Treatments tested in this trial
- CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
Treatment groups
41 Participants
are divided into 1 treatment groupLocations
7California
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program94063, Redwood City United States
Colorado
University of Colorado Anschutz Medical Campus80045, Aurora United States
Florida
University of Miami33136, Miami United States
Illinois
Northwestern University60611, Chicago United States
Sponsors and collaborators
CereGate Inc.
Lead sponsor
Source ClinicalTrials.gov