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A Mixed-Methods Exploratory Pilot Study of the Investigational MYNERVA Leia Sensory Prosthesis in U.S. Adults With Peripheral Neuropathy (MYN-L001-002)

21 september 2026 bijgewerkt door: Mynerva Inc.

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Mississippi
      • Ocean Springs, Mississippi, Verenigde Staten, 39564
        • Foot Specialists of South Mississippi

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Leia Sensory Prosthesis

Participants use the device during a single supervised session at the clinic
Apparaat: Leia Sensory Prosthesis

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in gait parameters
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Single-leg stance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At visit 1 (Day 1) before the intervention

Assessment of previous falls
At visit 1 (Day 1) before the intervention
Usability and patient satisfaction
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mynerva Inc.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

18 september 2026

Primaire voltooiing (Geschat)

18 september 2027

Studie voltooiing (Geschat)

31 maart 2028

Studieregistratiedata

Eerst ingediend

4 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 september 2026

Eerst geplaatst (Werkelijk)

24 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MYN-L001-002
  • Unique Device Identifiers (Andere identificatie: GS1)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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