Use of CereGate Therapy for Freezing of Gait in PD

Parkinson Disease Clinical Trial

Official title: 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

Clinical Trial Summary

A Multi-Center, Controlled Study to Evaluate Use of CereGate Therapy to Reduce Freezing of Gait in Participants Diagnosed with Parkinson's Disease.

Clinical Trial 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 five (5) sites in the United States. A maximum of 15 subjects may be enrolled at any site. ;

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Freezing of Gait
• Parkinson Disease

• NCT number: NCT05292794
• Study type: Interventional
• Source: CereGate Inc.
• Contact: Brian Blischak
• Phone: 972-816-4484
• Email: brian@ceregate.com
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Completion date: February 2025