Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374264
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-10
Brief Title:
Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder
Sponsor:
MedRhythms Inc
Organization:
MedRhythms Inc
Study Overview
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
aNiMatO
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None