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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Neuromyelitis Optica Spectrum Disorder
• Intervention / Treatment: Device: MR-C-014

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Sheperd Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Use of device 3 times per week (for 30 minutes) for 8 weeks - for a total of 24 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Participant acceptability of MR-C-014	Assesses participant engagement via logged use of MR-C-014	Intervention period (of up to 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minute Walk Test (6MWT)	Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance (distance in meters)	Baseline and closing (up to 8 weeks)
Number of walks per week	Assesses adherence to recommended frequency of MR-C-014 use. Recommended frequency is 3 walks per week for 8 weeks.	Weekly for up to 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors	Assesses spatiotemporal symmetry of gait in NMOSD patients with a gait deficit while using MR-C-014	Baseline and closing (up to 8 weeks)
Spatiotemporal variability of gait as measured by the MR-C-014 sensors	Assesses spatiotemporal variability of gait in NMOSD patients with a gait deficit while using MR-C-014	Baseline and closing (up to 8 weeks)
Stride length as measured by the MR-C-014 sensors	Assesses stride length in NMOSD patients with a gait deficit while using MR-C-014	Baseline and closing (up to 8 weeks)
Falls Efficacy Scale-International (FES-I)	A 16-item self-administered questionnaire designed to assess fear of falling in mainly community-dwelling older population. Minimum score = 16 (no concern about falling); maximum score = 64 (severe concern about falling).	Baseline and closing (up to 8 weeks)
Number of falls as recorded in Falls Diary	Assesses number of falls in NMOSD patients with a gait deficit	Weekly for up to 8 weeks
Multiple Sclerosis Walking Scale (MSWS-12)	A self-report measure of the impact of MS on the individual's walking ability. Minimum score = 12 (not at all impacted); maximum score = 60 (extremely impacted).	Baseline and closing (up to 8 weeks)
Visual Analogue Scale (VAS)	A validated, subjective measure to assess pain intensity. Minimum score = 0 (no pain); maximum score = 10 (worst pain possible).	Baseline and closing (up to 8 weeks)
Generalized Anxiety Disorder-7 (GAD-7)	A self-administered patient questionnaire used as a screening tool and severity measure for generalized anxiety disorder. Minimum score = 0 (no anxiety); maximum score = 21 (severe anxiety).	Baseline and closing (up to 8 weeks)
9 Hole Peg Test (9-HPT)	A standardized, quantitative assessment used to measure finger dexterity (time in seconds).	Baseline and closing (up to 8 weeks)
Symbol Digit Modalities Test (SDMT)	A measure of cognitive processing speed. Minimum score = 0; maximum score = 110. Higher score indicates faster processing speed.	Baseline and closing (up to 8 weeks)
Fatigue Scale for Motor and Cognitive Functions (FSMC)	A 20-item scale developed as a measure of cognitive and motor fatigue for people with MS. Minimum score = 20; maximum score = 100. Higher score indicates higher level of fatigue.	Baseline and closing (up to 8 weeks)
Expanded Disability Status Scale (EDSS) Ambulation Score	The EDSS is a scale for assessing the level of disability in people with multiple sclerosis The ambulation score specifically assesses impairment to ambulation. Minimum score = 0; maximum score = 10. Higher score indicates greater disability.	Baseline and closing (up to 8 weeks)
Activities-Specific Balance Confidence Scale (ABC)	A self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Minimum score = 0 (no confidence); maximum score = 100 (complete confidence).	Baseline and closing (up to 8 weeks)
Patient Experience and Satisfaction Survey	Assesses patient satisfaction with the MR-C-014 device	Closing (at up to 8 weeks)

Collaborators and Investigators

• Sponsor: MedRhythms, Inc.
• Collaborators: Alexion Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Eric Klawiter, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Neurology; Rhythmic Auditory Stimulation (RAS)
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Neuromyelitis Optica
• Other Study ID Numbers: NM100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No