Clinical trial NCT05292794: 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
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Freezing of Gait
Deep Brain Stimulation
Lead sponsor: CereGate Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 eight (8) sites in the United States. A maximum of 15 subjects may be enrolled at any site.

Eligibility criteria: 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 FDA to be used with Gevia or Genus IPGs.
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 80 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 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).
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 Barrier Course Figures of 8 (TBC-F8) pre-CG therapy (ON Medications/ON DBS /OFF CG).

Primary outcomes:
measure: Primary Efficacy Objective
timeFrame: Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)
Secondary outcomes:
measure: Secondary Efficacy Endpoint
timeFrame: Pre-CG therapy to post-CG-therapy follow-up Day 61 Visit (Day60 Visit +1-8d).
Other outcomes:
measure: Safety Endpoints
timeFrame: From 1st Screening Visit through Day 61 (Day 60 Visit +1-8d) follow-up visit.
Locations:
city: Redwood City
country: United States
facility: Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: CereGate Inc.
name: Brian Blischak
role: STUDY_CHAIR
References: