This is a US-specific pilot study to evaluate the short- and long-term effects of the investigational MYNERVA Leia Sensory Prosthesis on gait, neuropathic symptoms and quality of life in US adults with peripheral neuropathy, and to capture insights on the device's usability and perceived clinical effects.
Signed informed consent prior to any study procedure
Adults ≥ 18 years
Clinical diagnosis of peripheral neuropathy, confirmed per site procedures
Gait or balance difficulties as self-reported and confirmed by single-leg stance < 30 seconds
Untreated/unhealed lesions of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near device use (e.g., untreated lymphedema, phlebitis, thrombo-phlebitis or varicose veins)
Untreated/unhealed fractures in the foot and ankle
Cancerous growth in the planned treatment area
Severe peripheral vascular disease (e.g., gangrene)
Single group
Leia Sensory Prosthesis
DeviceA non-invasive wearable device used to evaluate the short- and long-term effects on gait, neuropathic symptoms and quality of life in US adults with peripheral neuropathy, and to capture insights on the device's usability and perceived clinical effects.
Change in gait parameters
using the 10-meter walking test
Single-leg stance
The single-leg stance test is a simple clinical assessment used to evaluate static balance and postural control. The patient is instructed to stand unassisted on one leg for up to 30 seconds, with eyes open and arms by the side. The test is performed in both legs. Inability to maintain the position for 30 seconds indicating impaired balance and increased risk of falls.
Timed-up and Go (TUG) in seconds
The Timed Up and Go (TUG) test assesses functional mobility. Participants are instructed to stand up from a chair, walk 3 metres at their usual pace, turn around, walk back to the chair, and sit down. The time from the command to start until the participant is seated again is recorded in seconds. A shorter time indicates better functional mobility.
Sensory function - Monofilament test
Sensitivity to pressure and touch
Quality of life (NORFOLK QOL-DN (in part)
Evaluates impact of intervention on daily function and well-being.
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