Leia sensory prosthesis for balance and gait in people with peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, sham-controlled study tests a wearable device intended to improve balance and gait in adults with peripheral neuropathy. Participants use either the active device or a sham version for a defined period, with safety, usability, and functional performance outcomes measured. The trial includes weekly sessions and home use, focusing on how well the device performs in daily activities and how comfortable and acceptable it is. Neurological confirmation and gait/balance criteria are used to enroll eligible participants, who must be able to walk without aids and maintain stable medications. The investigation takes place at multiple European centers led by MYNERVA AG.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Ensemble Hospitalier de la Côte (EHC)
  Morges, Switzerland Recruiting
• Hôpital de la Tour
  Meyrin, Switzerland Not yet recruiting
• Universitätsklinik Balgrist
  Zurich, Switzerland Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.