Use of CereGate Therapy for Freezing of Gait in PD
Start Date
4/18/2022
Completion Date
7/1/2027
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.
Eligibility Criteria
Age Range: 21 years to 80 years
Interventions
CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
Conditions
Locations
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
Redwood City, California 94063
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
University of Miami
Miami, Florida 33136
United States
Northwestern University
Chicago, Illinois 60611
United States
Wake Forest University
Winston-Salem, North Carolina 27157
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
University of Washington
Seattle, Washington 98195
United States