By InvitationNot Applicable

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

United States30 participantsStarted 2024-11-12

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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).
✓. Has a reciprocal gait pattern.
✓. Ability and willingness to provide Informed Consent.

Exclusion criteria

✕. 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).
✕. 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).

What they're measuring

Participant acceptability of MR-C-014

Timeframe: Intervention period (of up to 8 weeks)

Number of device-related adverse events (AEs)

Timeframe: Weekly for up to 8 weeks

Trial details

NCT IDNCT06374264

SponsorMedRhythms, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Neuromyelitis Optica Spectrum Disorder trials