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 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Use of device 3 times per week (for 30 minutes) for 8 weeks - for a total of 24 sessions.
Sheperd Center
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Participant acceptability of MR-C-014
Assesses participant engagement via logged use of MR-C-014
Time frame: 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
Time frame: Weekly for up to 8 weeks
6-Minute Walk Test (6MWT)
Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance (distance in meters)
Time frame: 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.
Time frame: Weekly for up to 8 weeks
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