MedRhythms, Inc.
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.
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 pr…
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 sp…
Use of device 3 times per week (for 30 minutes) for 8 weeks - for a total of 24 sessions.
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