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

NCT07840157 | Not Yet Recruiting FDA Device

• 2 other identifiers: MYN-L001-002Unique Device Identifiers
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Neuropathy

Keywords

Peripheral neuropathy; Sensory Prosthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Single-leg stance

  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

  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

  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)

  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

  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)

Study Arms (1)

Leia Sensory Prosthesis

EXPERIMENTAL

Participants use the device during a single supervised session at the clinic

Device: Leia Sensory Prosthesis

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.

Leia Sensory Prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mynerva Inc.: lead

Study Sites (1)

Foot Specialists of South Mississippi

Ocean Springs, Mississippi, 39564, United States

Location

Related Publications (1)

• 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.

  PMID: 39738088 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 24, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): September 18, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)