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Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder | Clinical Trials | Clareo Health

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

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

NCT06374264•MedRhythms, Inc.

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (2)

Sheperd Center

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

November 12, 2024

Primary Completion Date

March 31, 2026

Completion Date

March 31, 2026

Last Updated

December 15, 2025

Enrollment

ESTIMATED participants

Conditions

Neuromyelitis Optica Spectrum Disorder

Interventions

MR-C-014

DEVICE

Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study

NCT07410039

Neuromyelitis Optica Spectrum Disorder Attack

View study

RECRUITING

Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies

NCT05966467

Neuromyelitis Optica Spectrum DisorderNMOSD+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study

Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies

The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

French Registry for Monitoring Pregnancies for Multiple Sclerosis

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder