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Testing CereGate for freezing while walking

Researchers study whether CereGate therapy reduces episodes when people with Parkinson’s feel unable to keep walking.

Testing a treatment or activity · Study reference: NCT05292794

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

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Looking for volunteers

Start (reported actual date)
2022-04-18
Main measurements finished (planned)
2027-06
Study finished (planned)
2027-07

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 21 years to 80 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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).
Full study name & original research details

Official study title

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

Short title used by the registry

Use of CereGate Therapy for Freezing of Gait in PD

Original description

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

Further description from the registry

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.

Conditions reported: Parkinson Disease; Freezing of Gait; Deep Brain Stimulation

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
Phases
NA
Sponsor
CereGate Inc.
Start date reported by registry
2022-04-18 (actual)

Registry updated: 2026-05-28 · Status last verified by the registry submitter: 2026-05

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Kathleen Kmiecik · 330-241-9098 · kathleen@ceregate.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Kaiser Permanente, KPNC Comprehensive Movement Disorders Program

Redwood City, California, United States

Recruiting

Elena Call, MD · 650-464-6321 · elena.call@kp.org

Elena Call, MD

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Recruiting

Drew Kern, MD · 303-724-4172 · drew.kern@cuanschutz.edu

Drew Kern, MD

University of Miami

Miami, Florida, United States

Recruiting

Ihtsham Haq, MD · 305-243-6732 · ihaq@med.miami.edu

Lissette Perez · 305-243-2172 · lperez4@miami.edu

Ihtsham Haq, MD

Corneliu Luca, MD

Taylor Peabody, MD

Northwestern University

Chicago, Illinois, United States

Recruiting

Neil Shetty, MD · 312-695-7950 · Neil.shetty@nm.org

Neil Shetty, MD

Joshua Rosenow, MD

Jessica Karl, PhD, PA-C

Wake Forest University

Winston-Salem, North Carolina, United States

Recruiting

Tonya Woosley, CRC · 336-716-9520 · twoosley@wakehealth.edu

Deepal Shah-Zamora, MD

Ha Green, PA

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Recruiting

Travis J Hassell, M.D. · 615-936-2025 · travis.j.hassell@vumc.org

Jackie Harris, RMA, CTRC III · 615-936-3833 · jacqueline.c.harris@vumc.org

Travis J Harris, M.D.

University of Washington

Seattle, Washington, United States

Recruiting

Sarah Simon · 206-221-2132 · ssimon3@uw.edu

Yi-Han (Anny) Lin, MD

John Sanderson, MD

Facility not reported

United States

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.