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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Mississippi
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Ocean Springs, Mississippi, Spojené státy, 39564
- Foot Specialists of South Mississippi
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in gait parameters
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Single-leg stance
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: At visit 1 (Day 1) before the intervention
|
Assessment of previous falls |
At visit 1 (Day 1) before the intervention
|
|
Usability and patient satisfaction
Časové okno: 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
Časové okno: 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)
|
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Safety Outcome
Časové okno: 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
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Safety Outcome
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MYN-L001-002
- Unique Device Identifiers (Jiný identifikátor: GS1)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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