Use of CereGate Therapy for Freezing of Gait in PD

May 25, 2026 updated by: CereGate Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Recruiting
        • Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
        • Contact:
        • Principal Investigator:
          • Elena Call, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
        • Principal Investigator:
          • Drew Kern, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Ihtsham Haq, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Corneliu Luca, MD
        • Sub-Investigator:
          • Taylor Peabody, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Sub-Investigator:
          • Joshua Rosenow, MD
        • Contact:
        • Sub-Investigator:
          • Jessica Karl, PhD, PA-C
        • Principal Investigator:
          • Neil Shetty, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University
        • Principal Investigator:
          • Deepal Shah-Zamora, MD
        • Sub-Investigator:
          • Ha Green, PA
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Travis J Harris, M.D.
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Yi-Han (Anny) Lin, MD
        • Sub-Investigator:
          • John Sanderson, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Objective
Time Frame: Pre-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).
Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Efficacy Endpoint
Time Frame: Pre-CG therapy to post-CG-therapy follow-up Day 61 Visit (Day60 Visit +1-8d).
The secondary objective of this study is to determine whether adjunctive use of CereGate therapy reduces FOG in participants diagnosed with PD as measured by mean percent change in excess arrhythmicity in the OFF-med/ON-DBS state.
Pre-CG therapy to post-CG-therapy follow-up Day 61 Visit (Day60 Visit +1-8d).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Endpoints
Time Frame: From 1st Screening Visit through Day 61 (Day 60 Visit +1-8d) follow-up visit.
Safety endpoints for this study will include the following by interventional condition (i.e., CereGate therapy ON or OFF): Proportion of participants who experience one or more stimulation-related serious adverse events (SAEs) Proportion of participants who experience any stimulation related adverse event Proportion of participants who experience each unique type of adverse event
From 1st Screening Visit through Day 61 (Day 60 Visit +1-8d) follow-up visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CereGate Inc.

Investigators

  • Study Chair: Kathleen Kmiecik, CereGate Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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