Use of CereGate Therapy for Freezing of Gait in PD
Condition(s) studied
Investigational drug(s) / intervention(s)
CereGate Software; BSN cDBS Programmer; BSN Burst Programmer: 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.
Study summary
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.
Eligibility
Primary outcome measure(s)
- Primary Efficacy Objective — Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)
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).
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Kaiser Permanente, KPNC Comprehensive Movement Disorders Program | Redwood City | California | Recruiting |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| Northwestern University | Chicago | Illinois | Recruiting |
| Wake Forest University | Winston-Salem | North Carolina | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| University of Washington | Seattle | Washington | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05292794 on ClinicalTrials.gov ↗ ← All trials in the USA