Status:
RECRUITING
Use of CereGate Therapy for Freezing of Gait in PD
Lead Sponsor:
CereGate Inc.
Conditions:
Parkinson Disease
Freezing of Gait
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.
Detailed Description
This is a multi-center, controlled, study in which participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System will...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Participant is less than 21 years of age or older than 80 years of age.
- Participant is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception as determined by the study investigator.
- Participant has a terminal illness with life expectancy of \< 1 year.
- Participant has history of recurrent or unprovoked seizures.
- Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria.
- Participant is in a very advanced stage of Parkinson's disease defined as: (i) Stage 5 as classified by the Hoehn and Yahr scale on medication and DBS (non-ambulatory) or (ii) participant requires an assistive device to perform the TBC OFF-meds /ON-DBS at the time of enrollment.
- Participant has a condition that makes walking difficult or could interfere with the study procedures or confound the evaluation of the study data, including musculoskeletal issues, peripheral neuropathies, hip/knee prostheses, or any visual or anatomical abnormality that affects their walking.
- Participant has disabling dyskinesias.
- Participant has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Items 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (CSSRS).
- Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).
- Participant has less than 8% arrhythmicity as measured in the Turning and Barrier Course Figures of 8 (TBC-F8) pre-CG therapy (ON Medications/ON DBS /OFF CG).
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05292794
Start Date
April 18 2022
End Date
July 1 2026
Last Update
May 31 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
Redwood City, California, United States, 94063
2
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
3
University of Miami
Miami, Florida, United States, 33136
4
Northwestern University
Chicago, Illinois, United States, 60611