Neuromyelitis Optica Spectrum DisorderaNiMatONCT06374264
Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder
A study testing MR-C-014 in people with Neuromyelitis Optica Spectrum Disorder, run by MedRhythms, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder
- What is being tested?
- MR-C-014
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Sheperd Center
Atlanta, Georgia, 30309
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Being tested
- MR-C-014
- Keywords
- Rhythmic Auditory Stimulation (RAS), Neurology
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-C-014Device
Use of device 3 times per week (for 30 minutes) for 8 weeks - for a total of 24 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be asked to use MR-C-014 for 24 sessions (30 minutes each), 3 times a week for 8 weeks. Receives: Device: MR-C-014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant acceptability of MR-C-014
Assesses participant engagement via logged use of MR-C-014
Measured: 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
Measured: Weekly for up to 8 weeks
Secondary outcomes (2)
6-Minute Walk Test (6MWT)
Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance (distance in meters)
Measured: 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.
Measured: Weekly for up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start12 Nov 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedRhythms, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alexion Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Eric Klawiter, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374264
- Sponsor's protocol ID
- NM100
- Acronym
- aNiMatO
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06374264
- Acronym / sponsor ID
- aNiMatO / NM100
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Keywords
- Rhythmic Auditory Stimulation (RAS), Neurology
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MedRhythms, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alexion Pharmaceuticals, Inc.
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: MR-C-014Participants will be asked to use MR-C-014 for 24 sessions (30 minutes each), 3 times a week for 8 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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").
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-C-014Use of device 3 times per week (for 30 minutes) for 8 weeks - for a total of 24 sessions. | Device | Intervention |
Primary outcome
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
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
2 secondary outcomes
6-Minute Walk Test (6MWT)
Time frame: Baseline and closing (up to 8 weeks)
Number of walks per week
Time frame: Weekly for up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Klawiter, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-C-014 in people with Neuromyelitis Optica Spectrum Disorder, run by MedRhythms, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant acceptability of MR-C-014 (time frame: Intervention period (of up to 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.