Use of CereGate Therapy for Freezing of Gait in PD

Last updated: November 24, 2024
Sponsor: CereGate Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

CereGate Software; BSN cDBS Programmer; BSN Burst Programmer

Clinical Study ID

NCT05292794
CG-001
  • Ages 21-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 FDAto be used with Gevia or Genus IPGs.

  2. Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamineagonist at the optimal doses as determined by a movement disorders neurologist.

  3. DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS

Exclusion

Exclusion Criteria:

  1. Participant is unable to understand the study requirements and the treatmentprocedures, or unwilling / unable to provide written informed consent before anystudy-specific tests or procedures are performed.

  2. Participant is unwilling or unable to comply with visit schedule and study relatedprocedures.

  3. Participant's medication regimen has not been stable for at least 28 days prior toCG initiation.

  4. Participant's DBS stimulation settings have not been stable for at least 28 daysprior 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 apositive urine pregnancy test or not using adequate contraception as determined bythe 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-DBSat the time of enrollment.

  11. Participant has a condition that makes walking difficult or could interfere with thestudy procedures or confound the evaluation of the study data, includingmusculoskeletal issues, peripheral neuropathies, hip/knee prostheses, or any visualor anatomical abnormality that affects their walking.

  12. Participant has disabling dyskinesias.

  13. Participant has a history of suicide attempt or current active suicidal ideation asdetermined by a positive response to Items 2-5 of suicide ideation sub-scale of theColumbia 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 BarrierCourse Figures of 8 (TBC-F8) pre-CG therapy (ON Medications/ON DBS /OFF CG).

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
Phase:
Study Start date:
April 18, 2022
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • St. Joseph's Hospital and Medical Center: Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Cedars Sinai Neurology

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Kaiser Permanente, KPNC Comprehensive Movement Disorders Program

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Stanford University School of Medicine, Center for Academic Medicine

    Stanford, California 94305
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

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