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

Neuromyelitis Optica Spectrum Disorder Clinical Trial

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

Status Not yet recruiting

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

• NCT number: NCT06374264
• Study type: Interventional
• Source: MedRhythms, Inc.
• Contact: Cecilia Carlowicz, MPH
• Phone: 207-200-4482
• Email: ccarlowicz@medrhythms.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Completion date: December 31, 2024