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Use of CereGate Therapy for Freezing of Gait in PD

Primary Purpose

Parkinson Disease, Freezing of Gait, Deep Brain Stimulation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CereGate Software; BSN cDBS Programmer; BSN Burst Programmer

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Cedars Sinai NeurologyRecruiting
Kaiser Permanente, KPNC Comprehensive Movement Disorders ProgramRecruiting
Stanford University School of Medicine, Center for Academic Medicine
University of Colorado Anschutz Medical CampusRecruiting
Northwestern UniversityRecruiting
University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD Patients treated with CereGate Software

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05292794

First Posted

February 23, 2022

Last Updated

October 11, 2023

Sponsor

CereGate Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05292794

Brief Title

Use of CereGate Therapy for Freezing of Gait in PD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 18, 2022 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CereGate Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Freezing of Gait, Deep Brain Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD Patients treated with CereGate Software

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

CereGate Software; BSN cDBS Programmer; BSN Burst Programmer

Intervention Description

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 Information:

Title

Primary Efficacy Objective

Description

Time Frame

Pre-CG therapy to post-CG-therapy follow-up Day 61 Visit (Day 60 ± 8)

Secondary Outcome Measure Information:

Title

Secondary Efficacy Endpoint

Description

Time Frame

Mean percent change in arrhythmicity during TBC-F8 (ON-med/ON-DBS) pre-CG therapy to 60 days post-CG Therapy.

Other Pre-specified Outcome Measures:

Title

Safety Endpoints

Description

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

Time Frame

From 1st Screening Visit through Day 61 (Day 60 ± 8) follow-up visit.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brian Blischak

Phone

972-816-4484

brian@ceregate.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Blischak

Organizational Affiliation

CereGate Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Cedars Sinai Neurology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michele Tagliati, MD

Phone

310-248-6938

michele.tagliati@cshs.org

First Name & Middle Initial & Last Name & Degree

Hayley Pomeroy

Phone

310-423-1697

hayley.pomeroy@cshs.org

Facility Name

Kaiser Permanente, KPNC Comprehensive Movement Disorders Program

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elena Call, MD

Phone

650-464-6321

elena.call@kp.org

Facility Name

Stanford University School of Medicine, Center for Academic Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Individual Site Status

Withdrawn

Facility Name

University of Colorado Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Drew Kern, MD

Phone

303-724-4172

drew.kern@cuanschutz.edu

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil Shetty, MD

Neil.shetty@nm.org

First Name & Middle Initial & Last Name & Degree

Justine Houseman

Phone

312-503-2128

Justine.houseman@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Joshua Rosenow, MD

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bianca Le

Phone

206-685-6602

bia7@uw.edu

First Name & Middle Initial & Last Name & Degree

Amy Good

Phone

206-543-5933

amygood@uw.edu

First Name & Middle Initial & Last Name & Degree

Yi-Han (Anny) Lin, MD

First Name & Middle Initial & Last Name & Degree

John Sanderson, MD

12. IPD Sharing Statement

Plan to Share IPD

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Use of CereGate Therapy for Freezing of Gait in PD

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