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

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.