Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder

NCT06374264 | Enrolling By Invitation FDA Device

• 1 other identifier: NM100
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuromyelitis Optica Spectrum Disorder

Keywords

Rhythmic Auditory Stimulation (RAS); Neurology

Outcome Measures

Primary Outcomes (2)

• Participant acceptability of MR-C-014

  Assesses participant engagement via logged use of MR-C-014

  Intervention period (of up to 8 weeks)

• Number of device-related adverse events (AEs)

  Assesses the safety of MR-C-014 in NMOSD patients with a gait deficit

  Weekly for up to 8 weeks

Secondary Outcomes (2)

• 6-Minute Walk Test (6MWT)

  Baseline and closing (up to 8 weeks)

• Number of walks per week

  Weekly for up to 8 weeks

Other Outcomes (14)

• Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors

  Baseline and closing (up to 8 weeks)

• Spatiotemporal variability of gait as measured by the MR-C-014 sensors

  Baseline and closing (up to 8 weeks)

• Stride length as measured by the MR-C-014 sensors

  Baseline and closing (up to 8 weeks)

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will be asked to use MR-C-014 for 24 sessions (30 minutes each), 3 times a week for 8 weeks.

Device: MR-C-014

Interventions

MR-C-014 DEVICE

Use of device 3 times per week (for 30 minutes) for 8 weeks - for a total of 24 sessions.

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years of age (inclusive).
• Able to read and/or understand English.
• Meets revised diagnostic criteria for NMOSD proposed by the International Panel for NMO Diagnosis (IPND) in 2015.
• Past clinical history of Transverse Myelitis as seen on imaging or as determined by clinical review by the investigator.
• Demonstrates an observable gait deficit resulting from a diagnosis of NMOSD as determined by the Investigator or medical history review.
• 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.
• 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.
• Ability and willingness to provide Informed Consent.

You may not qualify if:

• Unable or unwilling to comply with study protocol.
• People who become pregnant or are pregnant (due to expected changes in gait patterns).
• Unable to safely participate in protocol-defined walking sessions of 30-minute duration as determined by the investigator.
• 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.
• Has an external lower limb prosthetic ("artificial limb").
• Initiated physical therapy for lower limb in the past 4 weeks or anticipated to start due to safety concerns (e.g., falls).
• Requires at least one seated rest during the T25FWT.
• Initiation, change, or discontinuation of disease-modifying therapy in the past 3 months known to affect gait (e.g., dalfampridine, corticosteroid, medications for spasticity).
• Recent NMOSD relapse (last 3 months) and/or hospitalization.
• 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.
• Treatment with a gait-based investigational intervention within the last 3 months. Enrollment in observational studies is allowed.
• 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.

Sponsors & Collaborators

• MedRhythms, Inc.: lead
• Alexion Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Sheperd Center

Atlanta, Georgia, 30309, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eric Klawiter, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 18, 2024
• Study Start: November 12, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)