Use of CereGate Therapy for Freezing of Gait in PD

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Description

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

Start Date
April 18, 2022
Completion Date
February 1, 2025
Enrollment
41
Date Posted
March 23, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Cedars Sinai Neurology
Los Angeles, California 90048, United States

Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
Redwood City, California 94063, United States

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045, United States

Northwestern University
Chicago, Illinois 60611, United States

University of Washington
Seattle, Washington 98195, United States

Eligibility

Minimum Age (years)
21
Maximum Age (years)
75
Eligibility Criteria
Inclusion Criteria:

Participant has implanted Boston Scientific Gevia STN-DBS system
Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist.
DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS

Exclusion Criteria:

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.
Participant is unwilling or unable to comply with visit schedule and study related procedures.
Participant's medication regimen has not been stable for at least 28 days prior to CG initiation.
Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation.
Participant is less than 21 years of age or older than 75 years of age.
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.
Participant has a terminal illness with life expectancy of < 1 year.
Participant has history of recurrent or unprovoked seizures.
Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria.
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.
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.
Participant has disabling dyskinesias.
Participant has significant cognitive impairment as indicated by MMSE- 2:SV score of ≤27.
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).
Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).
Participant has less than 8% arrhythmicity as measured in the Turning and Barrier Course Figures of 8 (TBC-F8) pre-CG therapy (OFF Medications/ON DBS /OFF CG).

Study Contact Info

Study Contact Name
Brian Blischak
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
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 five (5) sites in the United States. A maximum of 15 subjects may be enrolled at any site.
NCTid (if applicable)
NCT05292794