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

Part of paid clinical trials in Ocean Springs, Mississippi.

Sponsor
Mynerva Inc.
Study ID
NCT07840157
Status
Not Yet Recruiting

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Conditions

  • Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Leia Sensory Prosthesis — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Sep 24, 2026
Start date
Sep 18, 2026
Status verified
Sep 2026
Primary completion
Sep 18, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change in gait parameters [ Time Frame: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session ]

Locations (1)

FacilityCityStateZIPSite coordinators
Foot Specialists of South MississippiOcean SpringsMississippi39564-

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Foot Specialists of South Mississippi· Ocean Springs, MS

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