A Mixed-Methods Exploratory Pilot Study of the Investigational MYNERVA Leia Sensory Prosthesis in U.S. Adults With Peripheral Neuropathy

Through a single, two-hour in-person session per participant, this study is intended to generate preliminary evidence on whether the Leia Sensory Prosthesis improves gait patterns and sensory function in US adults with peripheral neuropathy, based on short-term device use.

A phone follow-up will inform on participant-reported clinical effects of the single use of Leia, and their duration.

Findings will also allow to gain a more comprehensive understanding of US demographic specifics to inform future device design, usability improvements, and potential adoption barriers ahead of further clinical development.

Inclusion criteria

• 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
• Able to walk without walking aids
• Stable supplements and medications ≥ 1 month before intervention and willing to maintain stability during 1 month following the intervention
• Willingness and ability to attend the initial in-person session (up to 2 hours) and follow-up calls.

Exclusion criteria

• 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)
• Implanted electrical devices or pacemakers
• Lower-limb orthoses/braces that cannot be removed for assessments
• Pregnant or breast-feeding females
• Usage of other medical devices for the relief of neuropathic symptoms during the study
• Current participation in any other clinical study using an investigational device or investigational drug
• Orthopedic conditions substantially limiting gait (e.g., failed back surgery syndrome (FBSS), recent hip or knee replacement, unstable fractures) as judged by the investigator
• Inability to perceive the stimulation (tested by MYNERVA staff during calibration)
• Cognitive impairment or poor command of English that preclude informed consent or answering questionnaires