Leia Sensory Prosthesis: A 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in gait parameters — At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session using the 10-meter walking test
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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