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

December 9, 2025 updated by: MedRhythms, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of device-related adverse events (AEs)
Time Frame: Weekly for up to 8 weeks
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
Time Frame: Intervention period (of up to 8 weeks)
Assesses participant engagement via logged use of MR-C-014
Intervention period (of up to 8 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test (6MWT)
Time Frame: Baseline and closing (up to 8 weeks)
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
Time Frame: Weekly for up to 8 weeks
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors
Time Frame: Baseline and closing (up to 8 weeks)
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
Time Frame: Baseline and closing (up to 8 weeks)
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
Time Frame: Baseline and closing (up to 8 weeks)
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)
Time Frame: Baseline and closing (up to 8 weeks)
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
Time Frame: Weekly for up to 8 weeks
Assesses number of falls in NMOSD patients with a gait deficit
Weekly for up to 8 weeks
Multiple Sclerosis Walking Scale (MSWS-12)
Time Frame: Baseline and closing (up to 8 weeks)
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)
Time Frame: Baseline and closing (up to 8 weeks)
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)
Time Frame: Baseline and closing (up to 8 weeks)
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)
Time Frame: Baseline and closing (up to 8 weeks)
A standardized, quantitative assessment used to measure finger dexterity (time in seconds).
Baseline and closing (up to 8 weeks)
Symbol Digit Modalities Test (SDMT)
Time Frame: Baseline and closing (up to 8 weeks)
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)
Time Frame: Baseline and closing (up to 8 weeks)
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
Time Frame: Baseline and closing (up to 8 weeks)
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)
Time Frame: Baseline and closing (up to 8 weeks)
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
Time Frame: Closing (at up to 8 weeks)
Assesses patient satisfaction with the MR-C-014 device
Closing (at up to 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedRhythms, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alexion Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Klawiter, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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