CereGate Therapy for Freezing of Gait in Parkinson's Disease
This study is testing a new way to use an existing Deep Brain Stimulation (DBS) system, called CereGate Therapy, for people with Parkinson's Disease (PD) who experience Freezing of Gait (FOG). CereGate Therapy uses your implanted DBS system in the STN (subthalamic nucleus) area of the brain to deliver two types of stimulation: one for general PD symptoms and another, called "bursting DBS," specifically to help with FOG. The study aims to see if CereGate Therapy can reduce FOG. You may be able to join if you are between 21 and 80 years old, have PD, and already have a compatible Boston Scientific Gevia™ or Genus™ R16 DBS system implanted. Success will be measured by changes in FOG from before to 60 days after starting CereGate Therapy. The study is currently unclear on its recruitment status.
- Study design
- This is a multi-center, controlled study involving up to 41 participants with Parkinson's Disease who already have a compatible DBS system. There is no randomization in this study.
- What's involved
- You would have five study visits over an expected duration of up to 104 days. These include two screening visits, an initiation visit, and two follow-up visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be followed up to 60 days after starting CereGate Therapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Use of CereGate Therapy for Freezing of Gait in PD
At a glance
Conditions
NCT05292794
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
Redwood City, Californiastudy coordinator listed
Recruiting
Northwestern University
Chicago, Illinoisstudy coordinator listed
Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Coloradostudy coordinator listed
Recruiting
University of Miami
Miami, Floridastudy coordinator listed
Recruiting
University of Washington
Seattle, Washingtonstudy coordinator listed
Recruiting
Vanderbilt University Medical Center
Nashville, Tennesseestudy coordinator listed
Recruiting
Wake Forest University
Winston-Salem, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Kathleen Kmiecik · STUDY_CHAIR · CereGate Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Primary Efficacy ObjectivePre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)
The primary objective of this study is to determine whether adjunctive use of CereGate therapy reduces Freezing of Gait in participants diagnosed with Parkinson's Disease in the ON-MEDS/ON-DBS state. The primary efficacy endpoint for this study is the mean percent change in excess arrhythmicity during Turning and Barriers Course Figures of 8 (TBC-F8) while ON-med/ON-DBS, pre-CG therapy to post-CG Therapy follow-up. The Opal wearable inertial measurement sensor (APDM Inc., Portland, OR) will be used to capture kinemetric data, from which the arrhythmicity will be extracted. Excess arrhythmicity will be calculated by subtracting the "normal" arrhythmicity (during TBC-F8 in age-matched controls).