NCT05292794

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: CereGate Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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 be assessed prior to initiation of CereGate (CG) therapy, and during CereGate therapy. No randomization will occur in this study. Participants will complete a total of five study visits (2 Screening Visits, Initiation Visit, day 60 follow-up and day 61 follow-up). The expected duration of participation in the clinical study is up to 104 days for each subject. Up to 41 participants diagnosed with PD previously implanted with a compatible STN-DBS System will be enrolled at up to eight (8) sites in the United States. A maximum of 15 subjects may be enrolled at any site. More information about the study can be found at www.fog-study.com.

Conditions

• Parkinson Disease
• Freezing of Gait
• Deep Brain Stimulation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-18
• Primary completion: 2027-06-01
• Completion: 2027-07-01
• First posted: 2022-03-23
• Last updated: 2026-02-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study