Mynerva Inc.
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.
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 clini…
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 lesio…
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.
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