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

Overview

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.

More information about the study can be found at www.fog-study.com.

Interventions

• 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 So

Primary outcome measures

• Primary Efficacy Objective [Time frame: Pre-CG therapy to post-CG-therapy follow-up Day 60 Visit (Day 60 ± 8)]

Secondary outcome measures (1)

• Secondary Efficacy Endpoint [Time frame: Pre-CG therapy to post-CG-therapy follow-up Day 61 Visit (Day60 Visit +1-8d).]

Eligibility criteria

Inclusion criteria

• 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.
• 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 80 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 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 (ON Medications/ON DBS /OFF CG).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 7 centers

• Kaiser Permanente, KPNC Comprehensive Movement Disorders Program — Redwood City
• University of Colorado Anschutz Medical Campus — Aurora
• University of Miami — Miami
• Northwestern University — Chicago
• Wake Forest University — Winston-Salem
• Vanderbilt University Medical Center — Nashville
• University of Washington — Seattle

Identifiers

NCT: NCT05292794 · CG-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗