Use of CereGate Therapy for Freezing of Gait in PD

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: Parkinson Disease; Freezing of Gait; Deep Brain Stimulation
• Intervention / Treatment: Device: CereGate Software; BSN cDBS Programmer; BSN Burst Programmer

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.

• Study Type: Interventional
• Enrollment (Estimated): 41
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Blischak; Phone Number: 972-816-4484; Email: brian@ceregate.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Neurology
      • Contact: Michele Tagliati, MD; Phone Number: 310-248-6938; Email: michele.tagliati@cshs.org
      • Contact: Hayley Pomeroy; Phone Number: 310-423-1697; Email: hayley.pomeroy@cshs.org
    • Redwood City, California, United States, 94063
      • Recruiting
      • Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
      • Contact: Elena Call, MD; Phone Number: 650-464-6321; Email: elena.call@kp.org
    • Stanford, California, United States, 94305
      • Withdrawn
      • Stanford University School of Medicine, Center for Academic Medicine
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Drew Kern, MD; Phone Number: 303-724-4172; Email: drew.kern@cuanschutz.edu
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Neil Shetty, MD; Email: Neil.shetty@nm.org
      • Contact: Justine Houseman; Phone Number: 312-503-2128; Email: Justine.houseman@northwestern.edu
      • Sub-Investigator: Joshua Rosenow, MD
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Amy Good; Phone Number: 206-543-5933; Email: amygood@uw.edu
      • Contact: Bianca Le; Phone Number: 206-685-6602; Email: bia7@uw.edu
      • Principal Investigator: Yi-Han (Anny) Lin, MD
      • Sub-Investigator: John Sanderson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant has implanted Boston Scientific Gevia STN-DBS system
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 75 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 significant cognitive impairment as indicated by MMSE- 2:SV score of ≤27.
14. 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).
15. Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations).
16. 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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

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	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 OFF-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 OFF-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 61 Visit (Day 60 ± 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Endpoint	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 ON-med/ON-DBS state.	Mean percent change in arrhythmicity during TBC-F8 (ON-med/ON-DBS) pre-CG therapy to 60 days post-CG Therapy.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints	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 ± 8) follow-up visit.

Collaborators and Investigators

• Sponsor: CereGate Inc.
• Investigators: Study Chair: Brian Blischak, CereGate Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

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): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• 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