Clinical trial NCT06374264: Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder
Official title: A Single Arm, Prospective, Multi-Center, Feasibility Study to Evaluate the Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder (NMOSD) Who Have an Impaired Gait
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Neuromyelitis Optica Spectrum Disorder
Keywords: Rhythmic Auditory Stimulation (RAS)
Neurology
Lead sponsor: MedRhythms, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Alexion Pharmaceuticals, Inc.
First posted: 2024-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit.

Detailed description: This is a single arm, prospective, multi-center feasibility study designed to evaluate the acceptability and safety of MR-C-014.

MR-C-014 is an autonomous neurorehabilitation system based on the principles of Rhythmic Auditory Stimulation (RAS) and is designed to operate digitally and autonomously. The core mechanism of RAS is "auditory-motor entrainment." Studies have shown that there is rich connectivity between the auditory and motor systems via multiple cortical and subcortical networks.

The MR-C-014 system consists of two foot sensors that measure walking, a locked touchscreen device preloaded with a proprietary software application, a headset, and charging equipment. The electronic components are powered by lithium-ion rechargeable batteries.

MR-C-014 is an investigational device.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years of age (inclusive).
2. Able to read and/or understand English.
3. Meets revised diagnostic criteria for NMOSD proposed by the International Panel for NMO Diagnosis (IPND) in 2015.
4. Past clinical history of Transverse Myelitis as seen on imaging or as determined by clinical review by the investigator.
5. Demonstrates an observable gait deficit resulting from a diagnosis of NMOSD as determined by the Investigator or medical history review.
6. Currently able to walk at a speed greater or equal to 0.4 m/s, but less than 1.5 m/s, as determined by walking speed during a Timed 25-Foot Walk Test (T25FWT) (cane(s), walking stick(s), crutch(es), wheeled walker, external functional neuromuscular stimulator(s), and ankle foot orthosis allowed).

   a. Note: if assistive devices are planned to be used during the Intervention Phase walking sessions, they should be used during the Screening, Baseline, and Closing visit gait assessments as well.
7. Has a reciprocal gait pattern.

   a. Note: a non-reciprocal gait pattern is defined as a 3-point step pattern. Participants must have a 2-point step pattern to qualify. Asymmetry seen in gait is acceptable.
8. Ability and willingness to provide Informed Consent.

Exclusion Criteria:

1. Unable or unwilling to comply with study protocol.
2. People who become pregnant or are pregnant (due to expected changes in gait patterns).
3. Unable to safely participate in protocol-defined walking sessions of 30-minute duration as determined by the investigator.
4. Significant co-morbid medical or neurological disease or injury, or treatment for such conditions that currently affects, or has potential to affect, participant gait for safety during participation in the study as determined by the investigator.
5. Has an external lower limb prosthetic ("artificial limb").
6. Initiated physical therapy for lower limb in the past 4 weeks or anticipated to start due to safety concerns (e.g., falls).
7. Requires at least one seated rest during the T25FWT.
8. Initiation, change, or discontinuation of disease-modifying therapy in the past 3 months known to affect gait (e.g., dalfampridine, corticosteroid, medications for spasticity).
9. Recent NMOSD relapse (last 3 months) and/or hospitalization.
10. Severe hearing impairment with or without the use of hearing aids, such that the participant cannot hear the rhythmic music stimulus consistently, as determined by participant and investigator.
11. Treatment with a gait-based investigational intervention within the last 3 months. Enrollment in observational studies is allowed.
12. Vulnerable populations as deemed inappropriate for study by investigator. For this protocol, vulnerable persons are considered to be those who are relatively (or absolutely) incapable of protecting their own interests.

Primary outcomes:
measure: Participant acceptability of MR-C-014
timeFrame: Intervention period (of up to 8 weeks)
measure: Number of device-related adverse events (AEs)
timeFrame: Weekly for up to 8 weeks
Secondary outcomes:
measure: 6-Minute Walk Test (6MWT)
timeFrame: Baseline and closing (up to 8 weeks)
measure: Number of walks per week
timeFrame: Weekly for up to 8 weeks
Other outcomes:
measure: Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors
timeFrame: Baseline and closing (up to 8 weeks)
measure: Spatiotemporal variability of gait as measured by the MR-C-014 sensors
timeFrame: Baseline and closing (up to 8 weeks)
measure: Stride length as measured by the MR-C-014 sensors
timeFrame: Baseline and closing (up to 8 weeks)
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Baseline and closing (up to 8 weeks)
measure: Number of falls as recorded in Falls Diary
timeFrame: Weekly for up to 8 weeks
measure: Multiple Sclerosis Walking Scale (MSWS-12)
timeFrame: Baseline and closing (up to 8 weeks)
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline and closing (up to 8 weeks)
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline and closing (up to 8 weeks)
measure: 9 Hole Peg Test (9-HPT)
timeFrame: Baseline and closing (up to 8 weeks)
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline and closing (up to 8 weeks)
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: Baseline and closing (up to 8 weeks)
measure: Expanded Disability Status Scale (EDSS) Ambulation Score
timeFrame: Baseline and closing (up to 8 weeks)
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: Baseline and closing (up to 8 weeks)
measure: Patient Experience and Satisfaction Survey
timeFrame: Closing (at up to 8 weeks)
Locations:
city: Atlanta
country: United States
facility: Sheperd Center
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Eric Klawiter, MD
role: PRINCIPAL_INVESTIGATOR
References: