Use of CereGate Therapy for Freezing of Gait in PD
NCT05292794 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2026-02-27
Summary
A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.
Conditions
- Parkinson Disease
- Freezing of Gait
- Deep Brain Stimulation
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
CereGate Inc.
lead INDUSTRY
Principal Investigators
-
Brian Blischak · CereGate Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-18
- Primary Completion
- 2027-06-30
- Completion
- 2027-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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