Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Peripheral Neuropathy

In brief

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.

Key facts

Study ID: NCT07236515
Run by: MYNERVA AG
People needed: 80
Starts: 2026-06-03
Expected to finish: 2028-08-01
Last updated by the study team: 2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Ensemble Hospitalier de la Côte (EHC) — Morges, Switzerland (enrolling)
Hôpital de la Tour — Meyrin, Switzerland
Universitätsklinik Balgrist — Zurich, Switzerland

Full record on ClinicalTrials.gov

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