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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Device: Leia Sensory Prosthesis

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Foot Specialists of South Mississippi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leia Sensory Prosthesis; Participants use the device during a single supervised session at the clinic	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gait parameters	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single-leg stance	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	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	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)	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	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)	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	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	Assessment of previous falls	At visit 1 (Day 1) before the intervention
Usability and patient satisfaction	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	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	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	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

Collaborators and Investigators

• Sponsor: Mynerva Inc.

Publications and helpful links

General Publications

• Gozzi N, Chee L, Odermatt I, Kikkert S, Preatoni G, Valle G, Pfender N, Beuschlein F, Wenderoth N, Zipser C, Raspopovic S. Wearable non-invasive neuroprosthesis for targeted sensory restoration in neuropathy. Nat Commun. 2024 Dec 30;15(1):10840. doi: 10.1038/s41467-024-55152-7.

Study record dates

Study Major Dates

• Study Start (Estimated): September 18, 2026
• Primary Completion (Estimated): September 18, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 21, 2026
• First Posted (Actual): September 24, 2026

Study Record Updates

• Last Update Posted (Actual): September 24, 2026
• Last Update Submitted That Met QC Criteria: September 21, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Peripheral neuropathy; Sensory Prosthesis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: MYN-L001-002; Unique Device Identifiers (Other Identifier: GS1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No