Use of CereGate Therapy for Freezing of Gait in PD

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292794
• Other study ID #: CG-001
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: CereGate Inc.
• Contact: Brian Blischak
• Phone: 972-816-4484
• Email: brian[@]ceregate.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Freezing of Gait
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Northwestern University	Chicago	Illinois
United States	Cedars Sinai Neurology	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Kaiser Permanente, KPNC Comprehensive Movement Disorders Program	Redwood City	California
United States	University of Washington	Seattle	Washington
United States	Stanford University School of Medicine, Center for Academic Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
CereGate Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.