A Mixed-Methods Exploratory Pilot Study of the Investigational MYNERVA Leia Sensory Prosthesis in U.S. Adults With Peripheral Neuropathy (MYN-L001-002)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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 clinical development.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Mississippi
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Ocean Springs, Mississippi, États-Unis, 39564
- Foot Specialists of South Mississippi
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 lesions of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near device 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)
- 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
- Inability to perceive the stimulation (tested by MYNERVA staff during calibration)
- Cognitive impairment or poor command of English that preclude informed consent or answering questionnaires
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Leia Sensory Prosthesis
Participants use the device during a single supervised session at the clinic |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in gait parameters
Délai: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
|
using the 10-meter walking test |
At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Single-leg stance
Délai: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
|
The single-leg stance test is a simple clinical assessment used to evaluate static balance and postural control. The patient is instructed to stand unassisted on one leg for up to 30 seconds, with eyes open and arms by the side. The test is performed in both legs. Inability to maintain the position for 30 seconds indicating impaired balance and increased risk of falls. |
At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
|
|
Timed-up and Go (TUG) in seconds
Délai: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
|
The Timed Up and Go (TUG) test assesses functional mobility. Participants are instructed to stand up from a chair, walk 3 metres at their usual pace, turn around, walk back to the chair, and sit down. The time from the command to start until the participant is seated again is recorded in seconds. A shorter time indicates better functional mobility. |
At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
|
|
Sensory function - Monofilament test
Délai: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) directly after the single 30 minutes treatment session
|
Sensitivity to pressure and touch |
At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) directly after the single 30 minutes treatment session
|
|
Quality of life (NORFOLK QOL-DN (in part)
Délai: At visit 1 (Day 1) before the intervention, 1 day after intervention (visit 2), monthly up to max. 6 months (only if patients perceived persisting benefit)
|
Evaluates impact of intervention on daily function and well-being. |
At visit 1 (Day 1) before the intervention, 1 day after intervention (visit 2), monthly up to max. 6 months (only if patients perceived persisting benefit)
|
|
EQ-5D (in part) questionnaire
Délai: At visit 1 (Day 1) before the intervention, 1 day after intervention (visit 2), monthly up to max. 6 months (only if patients perceived persisting benefit)
|
Evaluates impact of intervention on daily function and well-being. |
At visit 1 (Day 1) before the intervention, 1 day after intervention (visit 2), monthly up to max. 6 months (only if patients perceived persisting benefit)
|
|
Neuropathic pain symptoms (NPSI questionnaire)
Délai: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) directly after the single 30 minutes treatment session
|
Captures changes in neuropathic pain intensity and quality. |
At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) directly after the single 30 minutes treatment session
|
|
Patient history including symptoms, patient journey, and treatments received related to peripheral neuropathy
Délai: At visit 1 (Day 1)
|
Patients are asked for their symptoms, disease progression, diagnostic pathway and treatments received related to peripheral neuropathy |
At visit 1 (Day 1)
|
|
Fall history: fall questionnaire
Délai: At visit 1 (Day 1) before the intervention
|
Assessment of previous falls |
At visit 1 (Day 1) before the intervention
|
|
Usability and patient satisfaction
Délai: At visit 1 (Day 1) directly after the single treatment session
|
Patients will provide feedback on usability, comfort and user-friendliness in a patient satisfaction questionaire. |
At visit 1 (Day 1) directly after the single treatment session
|
|
Patient-reported perceived clinical effects after stimulation
Délai: 1 day after intervention (visit 2), monthly until the effect is not persisting anymore or latest at 6 monts (whatever occurrs first)
|
Patients are asked for perceived clinical effect after stimulation via phone call follow-up |
1 day after intervention (visit 2), monthly until the effect is not persisting anymore or latest at 6 monts (whatever occurrs first)
|
|
Safety Outcome
Délai: At visit 1 (Day 1) during the single 30 minutes treatment session until the maximal 6 months follow-up period ends
|
All Adverse events (AEs): incidence, severity, seriousness, relatedness to device/procedures |
At visit 1 (Day 1) during the single 30 minutes treatment session until the maximal 6 months follow-up period ends
|
|
Safety Outcome
Délai: At visit 1 (Day 1) during the single 30 minutes treatment session until the maximal 6 months follow-up period ends
|
All Device deficiencies: number, type, corrective actions |
At visit 1 (Day 1) during the single 30 minutes treatment session until the maximal 6 months follow-up period ends
|
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Première soumission répondant aux critères de contrôle qualité
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Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MYN-L001-002
- Unique Device Identifiers (Autre identifiant: GS1)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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