Recruiting

CereGate Therapy

Sponsor:

CereGate Inc.

Code:

NCT05292794

Conditions

Parkinson Disease

Freezing of Gait

Deep Brain Stimulation

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

CereGate Software; BSN cDBS Programmer; BSN Burst Programmer

Study Details

Brief summary:

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

Conditions

Parkinson Disease

Freezing of Gait

Deep Brain Stimulation

Study ID

NCT05292794

Start date

Apr 18, 2022

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

41 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PD Patients treated with CereGate Software

This singular arm contains participants diagnosed with Parkinson's Disease (PD) and previously implanted with a subthalamic nucleus deep brain stimulation (STN-DBS) System. Participants will use the CereGate software for 60(+/-8) days on demand.

Interventions

CereGate 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.

Primary outcome measure

  • Primary Efficacy Objective [ Time Frame: Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8) ]

Central Contacts and Locations

Central contacts

Locations

Kaiser Permanente, KPNC Comprehensive Movement Disorders Program

Recruiting

Redwood City, California, United States, 94063

Contacts

Principal Investigator:

Elena Call, MD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Drew Kern, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Ihtsham Haq, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Neil Shetty, MD

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Deepal Shah-Zamora, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

Travis J Harris, M.D.

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Principal Investigator:

Yi-Han (Anny) Lin, MD

More Information

Sponsor

CereGate Inc.

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Parkinson Disease
  • Parkinson's Disease
  • Freezing of Gait
  • Freezing of Gait Symptoms in Parkinson Disease
  • Gait Disorders
  • Gait Disorders, Neurologic
  • Gait Disorder, Sensorimotor
  • Motor Disorder
  • Gait Impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by CereGate Inc. on 2026-05-28.