--- title: Reduce freezing of gait episodes nct_id: NCT05292794 phase: NA status: RECRUITING sponsor: CereGate Inc. study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT05292794" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05292794" last_fetched: "2026-05-10T14:02:21.016Z" source: "Parkinson's Pathways (curated)" --- # Reduce freezing of gait episodes **Goal (in five words):** Reduce freezing of gait episodes **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 **Trial ID:** [NCT05292794](https://clinicaltrials.gov/study/NCT05292794) ## Key Facts - **Phase:** NA - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** CereGate Inc. - **Target Enrollment:** 41 participants - **Start Date:** 2022-04-18 - **Completion Date:** 2027-06 - **Conditions:** Parkinson Disease, Freezing of Gait, Deep Brain Stimulation - **Interventions:** CereGate Software; BSN cDBS Programmer; BSN Burst Programmer - **Intervention Types:** DEVICE ## Summary For Families Aiming to cut down freezing of gait episodes in people with Parkinson's who already have subthalamic nucleus deep brain stimulation, so walking becomes more reliable and safer. The approach loads CereGate software onto compatible Boston Scientific Gevia or Genus R16 implantable pulse generators and programmers, changing the timing and pattern of electrical pulses sent to the subthalamic nucleus (for example coordinated burst or continuous DBS modes) to better interrupt the brain circuits that trigger freezing, while being used alongside stable levodopa or dopamine agonist therapy. The trial seeks adults 21 to 80 who already have a Gevia or Genus IPG connected to FDA-approved leads, who are on stable dopaminergic medications and stable, optimized DBS settings with documented motor benefit; people who are non-ambulatory, need major walking aids, have unstable meds or DBS, or several other medical exclusions are not eligible. ## Eligibility - **Minimum age:** 21 Years - **Maximum age:** 80 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: 1. Participant has an implanted STN-DBS system with Boston Scientific Gevia™ or Genus™ R16 IPG connected to any brand lead or extension that have been approved by the FDA to be used with Gevia or Genus IPGs. 2. Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist. 3. DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS Exclusion Criteria: 1. Participant is unable to understand the study requirements and the treatment procedures, or unwilling / unable to provide written informed consent before any study-specific tests or procedures are performed. 2. Participant is unwilling or unable to comply with visit schedule and study related procedures. 3. Participant's medication regimen has not been stable for at least 28 days prior to CG initiation. 4. Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation. 5. Participant is less than 21 years of age or older than 80 years of age. 6. Participant is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception as determined by the study investigator. 7. Participant has a terminal illness with life expectancy of \< 1 year. 8. Participant has history of recurrent or unprovoked seizures. 9. Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria. 10. Participant is in a very advanced stage of Parkinson's disease defined as: (i) Stage 5 as classified by the Hoehn and Yahr scale on medication and DBS (non-ambulatory) or (ii) participant requires an assistive device to perform the TBC OFF-meds /ON-DBS at the time of enrollment. 11. Participant has a condition that makes walking difficult or could interfere with the study procedures or confound the evaluation of the study data, including musculoskeletal issues, peripheral neuropathies, hip/knee prostheses, or any visual or anatomical abnormality that affects their walking. 12. Participant has disabling dyskinesias. 13. Participant has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Items 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (CSSRS). 14. Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations). 15. Participant has less than 8% arrhythmicity as measured in the Turning and Barrier Course Figures of 8 (TBC-F8) pre-CG therapy (ON Medications/ON DBS /OFF CG). ``` ## Locations (7) - Kaiser Permanente, KPNC Comprehensive Movement Disorders Program, Redwood City, California, United States _(37.4852, -122.2364)_ - Elena Call, MD — (CONTACT) — 650-464-6321 — elena.call@kp.org - Elena Call, MD — (PRINCIPAL_INVESTIGATOR) - University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States _(39.7294, -104.8319)_ - Drew Kern, MD — (CONTACT) — 303-724-4172 — drew.kern@cuanschutz.edu - Drew Kern, MD — (PRINCIPAL_INVESTIGATOR) - University of Miami, Miami, Florida, United States _(25.7743, -80.1937)_ - Ihtsham Haq, MD — (CONTACT) — 305-243-6732 — ihaq@med.miami.edu - Lissette Perez — (CONTACT) — 305-243-2172 — lperez4@miami.edu - Ihtsham Haq, MD — (PRINCIPAL_INVESTIGATOR) - Corneliu Luca, MD — (SUB_INVESTIGATOR) - Taylor Peabody, MD — (SUB_INVESTIGATOR) - Northwestern University, Chicago, Illinois, United States _(41.8500, -87.6500)_ - Neil Shetty, MD — (CONTACT) — 312-695-7950 — Neil.shetty@nm.org - Neil Shetty, MD — (PRINCIPAL_INVESTIGATOR) - Joshua Rosenow, MD — (SUB_INVESTIGATOR) - Jessica Karl, PhD, PA-C — (SUB_INVESTIGATOR) - Wake Forest University, Winston-Salem, North Carolina, United States _(36.0999, -80.2442)_ - Tonya Woosley, CRC — (CONTACT) — 336-716-9520 — twoosley@wakehealth.edu - Deepal Shah-Zamora, MD — (PRINCIPAL_INVESTIGATOR) - Ha Green, PA — (SUB_INVESTIGATOR) - Vanderbilt University Medical Center, Nashville, Tennessee, United States _(36.1659, -86.7844)_ - Travis J Hassell, M.D. — (CONTACT) — 615-936-2025 — travis.j.hassell@vumc.org - Jackie Harris, RMA, CTRC III — (CONTACT) — 615-936-3833 — jacqueline.c.harris@vumc.org - Travis J Harris, M.D. — (PRINCIPAL_INVESTIGATOR) - University of Washington, Seattle, Washington, United States _(47.6062, -122.3321)_ - Sarah Simon — (CONTACT) — 206-221-2132 — ssimon3@uw.edu - Yi-Han (Anny) Lin, MD — (PRINCIPAL_INVESTIGATOR) - John Sanderson, MD — (SUB_INVESTIGATOR) ## Central Contacts - Brian Blischak — (CONTACT) — 972-816-4484 — brian@ceregate.com --- *Canonical: https://parkinsonspathways.com/trial/NCT05292794* *HTML version: https://parkinsonspathways.com/trial/NCT05292794* *Source data: https://clinicaltrials.gov/study/NCT05292794*