Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy
Randomized, Sham-Controlled, Multicenter Investigation of the Leia Sensory Prosthesis on Gait and Balance in Peripheral Neuropathy.
MYNERVA AG
80 participants
Jun 3, 2026
INTERVENTIONAL
Conditions
Summary
This study will evaluate a wearable device intended to support balance and gait in adults with peripheral neuropathy. Participants will use the device for a defined period, and outcomes related to safety, usability, and functional performance will be assessed.
Eligibility
Inclusion Criteria7
- Signed informed consent prior to any study procedure
- Adults ≥ 18 years
- Clinical diagnosis of peripheral neuropathy, confirmed per site procedures and neurophysiological testing (e.g. NCV)
- Gait or balance difficulties as self-reported and confirmed by Functional Gait Assessment (FGA score ≤ 23) and/or single-leg stance < 30 seconds
- Able to walk without walking aids
- Stable supplements and medications ≥ 1 month before baseline and willing to maintain stability during the investigation (same dosage and same medication within the last month)
- Willingness and ability to attend weekly sessions, perform home use, and return for follow-up
Exclusion Criteria12
- Untreated/unhealed lesion of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near product 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)
- Cognitive impairment that precludes informed consent or device use
- 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
- For patients who have been randomized in the active treatment group only: Incapability to perceive somatotopic sensations (tested at screening by MYNERVA staff)
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Interventions
A non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy.
A sham version of the wearable device without active functionality.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07236515