Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy

NCT07236515 | Recruiting

• 2 other identifiers: MYN-L001-001Unique Device Identifiers
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate a wearable device intended to support balance and gait in adults with peripheral neuropathy. Participants will use the device for a defined period, and outcomes related to safety, usability, and functional performance will be assessed.

Conditions

Peripheral Neuropathy

Keywords

Peripheral neuropathy; Sensory Prosthesis

Outcome Measures

Primary Outcomes (1)

• Functional Gait Assessment (FGA) total score

  The FGA is a validated clinical scale that assesses gait function and balance under various walking tasks.

  Change in Functional Gait Assessment (FGA) total score from baseline (day 0) to day 56.

Secondary Outcomes (14)

• Functional Gait Assessment (FGA) total score

  From baseline (day 0) to the end of the supervised period (day 28), change from day 28 to day 56, and evaluation of evolution across all timepoints, with and without stimulation

• Timed-up and Go (TUG) in seconds

  Change from Baseline to day 56

• Neuropathic pain symptoms (NPSI questionnaire)

  Change from baseline to each of the follow-up time points (day 7, 14, 28, 35, 42, 49, 56 and 80)

• Quality of life (NORFOLK QOL-DN, EQ-5D-5L questionnaire)

  Change from baseline to day 28, day 56 and day 80

• Sensory function - Monofilament test

  Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28 and 56)

Other Outcomes (3)

• Exploratory - Sensory function - Temperature measurement using the thermal imaging camera

  Change from baseline value from day 7 prestimulation to follow-up time points day 28 and 56

• Safety Outcome

  through study completion, an average of 4 months

• Safety Outcome

  through study completion, an average of 4 months

Study Arms (2)

Active Device

EXPERIMENTAL

Participants use the active wearable device during the study period.

Device: Active wearable device

Sham Device

SHAM COMPARATOR

Participants use a sham version of the wearable device without active functionality.

Device: Sham wearable device

Interventions

Active wearable device DEVICE

A non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy.

Active Device

Sham wearable device DEVICE

A sham version of the wearable device without active functionality.

Sham Device

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 and neurophysiological testing (e.g. NCV)
• Gait or balance difficulties as self-reported and confirmed by Functional Gait Assessment (FGA score ≤ 23) and/or single-leg stance \< 30 seconds
• Able to walk without walking aids
• Stable supplements and medications ≥ 1 month before baseline and willing to maintain stability during the investigation (same dosage and same medication within the last month)
• Willingness and ability to attend weekly sessions, perform home use, and return for follow-up

You may not qualify if:

• Untreated/unhealed lesion of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near product 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)
• Cognitive impairment that precludes informed consent or device use
• 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
• For patients who have been randomized in the active treatment group only: Incapability to perceive somatotopic sensations (tested at screening by MYNERVA staff)

Sponsors & Collaborators

• MYNERVA AG: lead

Study Sites (3)

Hôpital de la Tour

Meyrin, 1217, Switzerland

NOT YET RECRUITING

Ensemble Hospitalier de la Côte (EHC)

Morges, 1110, Switzerland

RECRUITING

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

NOT YET RECRUITING

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessors are masked to group allocation (active vs. sham). A subset of care providers responsible for device setup and allocation is unblinded due to practical requirements, while other care providers interacting with participants remain blinded whenever feasible. Investigators at the site have access to allocation information if needed for safety or clinical decision-making.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, sham-controlled, multicenter.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: June 3, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

CH (3)