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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
DeviceCereGate'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.
Treatment groups
41 Participants
are divided into 1 treatment groupGroup A: PD Patients treated with CereGate SoftwareExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)Secondary outcomes
1
Secondary Efficacy Endpoint
The secondary objective of this study is to determine whether adjunctive use of CereGate therapy reduces FOG in participants diagnosed with PD as measured by mean percent change in excess arrhythmicity in the OFF-med/ON-DBS state.
Time frame
Pre-CG therapy to post-CG-therapy follow-up Day 61 Visit (Day60 Visit +1-8d).Other outcomes
1
Safety Endpoints
Safety endpoints for this study will include the following by interventional condition (i.e., CereGate therapy ON or OFF): Proportion of participants who experience one or more stimulation-related serious adverse events (SAEs) Proportion of participants who experience any stimulation related adverse event Proportion of participants who experience each unique type of adverse event
Time frame
From 1st Screening Visit through Day 61 (Day 60 Visit +1-8d) follow-up visit.Sponsors and contacts
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Source ClinicalTrials.gov