NCT06374264

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: MedRhythms, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	MR-C-014	Use of device 3 times per week (for 30 minutes) for 8 weeks - for a total of 24 sessions.

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-04-18
• Last updated: 2025-12-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study