Clinical study with the neurostimulation sock 'Leia' to improve gait and balance in patients with nerve damage in the feet, conducted in several hospitals with a test group and a control group (non-activated Leia sock) without the patient or investigator knowing which group the patient is in (double-blind)
Résumé de l'étude
This study investigates whether Leia, a specially developed sensory prosthesis, can improve balance and gait stability in people with peripheral neuropathy. Peripheral neuropathy can reduce sensitivity in the feet, making it harder to properly feel the ground and walk safely. This often leads to an unstable gait and an increased risk of falls. Leia aims to replace or enhance part of this lost sensation through gentle, targeted vibrations, allowing the brain to receive clearer information about foot position and movement. The study will examine: - whether Leia improves balance - whether walking becomes safer and more stable - how comfortable and user-friendly the device is - whether any side effects or problems occur during daily use. Participants with a confirmed diagnosis of peripheral neuropathy will use the sensory prosthesis Leia over a defined period. Balance, gait, and user experience will be measured. Participation is voluntary. The results will help plan a larger follow-up study and support the development of a medical device intended to assist people with loss of sensation in their feet.
(BASEC)
Intervention étudiée
The intervention being studied is Leia, a wearable sensory prosthesis designed to support the balance and gait of people with peripheral neuropathy. Leia is a soft, textile-based sensory neurostimulation prosthesis that sends gentle, targeted neurostimulation signals to the ankle. These signals are intended to replace or enhance the sensory information that is often reduced or lost due to peripheral neuropathy. Peripheral neuropathy often impairs the ability to perceive pressure on the foot and ground contact. This sensory loss contributes to instability, altered gait patterns, and an increased risk of falls. Leia aims to compensate for this reduced sensitivity by providing structured electrical stimulation that can help the brain better interpret the position, load, and movement of the foot while standing and walking. The device consists of a sock with built-in electrode sensors and a small control unit. The system generates specific electrical stimulation patterns in response to foot contact and postural changes. These signals are designed to be intuitive and unobtrusive, allowing participants to wear the device during their normal daily activities. In this study, participants diagnosed with peripheral neuropathy will use the sensory prosthesis Leia for a specified period. The study will assess whether the device improves balance, increases gait stability, and is safe and acceptable for daily use. No medication will be used. The intervention is a non-invasive, wearable device that provides targeted sensory stimulation to the foot and is used as a medical device to partially replace or enhance missing or impaired sensory perception. The results of this study will provide initial clinical evidence for the feasibility, usability, safety, and potential functional benefits of Leia.
(BASEC)
Maladie en cours d'investigation
Peripheral Neuropathy
(BASEC)
1. Signed informed consent prior to any study procedures. 2. Age ≥ 18 years at the time of consent. 3. Clinical diagnosis of peripheral neuropathy, confirmed by clinical examination and neurophysiological tests (e.g., nerve conduction velocity, NCV). 4. Gait or balance disorders, self-reported and confirmed by the Functional Gait Assessment (FGA, score ≤ 23) and/or single-leg stand < 30 seconds. 5. Ability to walk independently without walking aids. 6. Stable supplements and medications for ≥ 1 month prior to the baseline examination and willingness to maintain stability during the study (same dosage and medication in the last month). 7. Willingness and ability to attend weekly sessions, perform home application, and return for follow-up visits. (BASEC)
Critères d'exclusion
1. Untreated or unhealed lesions of any kind (e.g., wounds, swelling, infections, inflamed skin areas, or rashes on the lower leg [foot and ankle] or in the area of product application; e.g., untreated lymphedema, phlebitis, thrombophlebitis, or varicose veins). 2. Untreated or unhealed fractures in the area of the foot and ankle. 3. Malignant tumor formation in the planned treatment area. 4. Severe peripheral vascular disease (e.g., gangrene). 5. Cognitive impairment that excludes informed consent or use of the device. 6. Implanted electrical devices or pacemakers. 7. Use of other medical devices to relieve neuropathic symptoms during the study. (BASEC)
Lieu de l’étude
Zurich, Autre
(BASEC)
Morges, VD Meyrin, GE
(BASEC)
Sponsor
Sponsor/ le promoteur: MYNERVA AG, Zürich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Greta Preatoni
+41 44 632 72 57
info@cluttermynerva.comMYNERVA AG
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
22.05.2026
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
RANDOMIZED, SHAMCONTROLLED, MULTICENTER INVESTIGATION OF THE Leia SENSORY PROSTHESIS TO IMPROVE GAIT AND BALANCE IN PERIPHERAL NEUROPATHY (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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