Use of CereGate Therapy for Freezing of Gait in PD
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed With Parkinson's Disease
1 other identifier
interventional
41
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Apr 2022
Longer than P75 for not_applicable parkinson-disease
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
April 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
February 27, 2026
February 1, 2026
5.1 years
February 23, 2022
February 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Efficacy Objective
The primary objective of this study is to determine whether adjunctive use of CereGate therapy reduces Freezing of Gait in participants diagnosed with Parkinson's Disease in the ON-MEDS/ON-DBS state. The primary efficacy endpoint for this study is the mean percent change in excess arrhythmicity during Turning and Barriers Course Figures of 8 (TBC-F8) while ON-med/ON-DBS, pre-CG therapy to post-CG Therapy follow-up. The Opal wearable inertial measurement sensor (APDM Inc., Portland, OR) will be used to capture kinemetric data, from which the arrhythmicity will be extracted. Excess arrhythmicity will be calculated by subtracting the "normal" arrhythmicity (during TBC-F8 in age-matched controls).
Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)
Secondary Outcomes (1)
Secondary Efficacy Endpoint
Pre-CG therapy to post-CG-therapy follow-up Day 61 Visit (Day60 Visit +1-8d).
Other Outcomes (1)
Safety Endpoints
From 1st Screening Visit through Day 61 (Day 60 Visit +1-8d) follow-up visit.
Study Arms (1)
PD Patients treated with CereGate Software
EXPERIMENTALThis singular arm contains participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System. Participants will use the CereGate software for 60(+/-8) days on demand.
Interventions
CereGate's objective is to, with a single DBS system implanted in the standard STN location for PD: (i) deliver conventional tonic DBS stimulation of STN-to mitigate dopamine-responsive symptoms; and concurrently (ii) deliver bursting DBS-induced "cueing" stimulation-to mitigate FOG. The sole function of CereGate Software is to guide the clinician through a systematic investigation of the stimulation parameter space to thereby configure / tune CereGate Therapy for each participant. CereGate Software proposes parameters for the clinician to evaluate and assists in documenting the response. It does not send commands to, nor control the output of, the DBS System.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CereGate Inc.lead
Study Sites (7)
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
Redwood City, California, 94063, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
University of Miami
Miami, Florida, 33136, United States
Northwestern University
Chicago, Illinois, 60611, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Brian Blischak
CereGate Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2022
First Posted
March 23, 2022
Study Start
April 18, 2022
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share