RecruitingNot ApplicableNCT05292794

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

Sponsor

CereGate Inc.

Enrollment

41 participants

Start Date

Apr 18, 2022

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Deep Brain Stimulation Freezing of Gait

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

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a therapy called CereGate to help people with Parkinson's disease who experience 'freezing of gait' — sudden episodes where their feet feel glued to the floor. The therapy works by adjusting settings on an already-implanted deep brain stimulation (DBS) device. **You may be eligible if...** - You have Parkinson's disease with an implanted deep brain stimulation (DBS) device (specifically a Boston Scientific Gevia™ or Genus™ R16 IPG) - You are being treated with carbidopa/levodopa and/or a dopamine agonist at the best doses your doctor has determined - Your DBS settings have already been optimized and show documented improvement in your motor symptoms **You may NOT be eligible if...** - You do not have a compatible Boston Scientific DBS implant - You are unable to understand study procedures or cannot provide written consent - You are unable to attend required study visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECereGate 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.

Locations(7)

Kaiser Permanente, KPNC Comprehensive Movement Disorders Program

Redwood City, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

University of Miami

Miami, Florida, United States

Northwestern University

Chicago, Illinois, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Washington

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05292794

Related Trials

The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy

NCT034574931 location

World Data on Ambroxol for Patients With GD and GBA Related PD

NCT043889693 locations