Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy (MYN-L001-001)

Randomized, Sham-Controlled, Multicenter Investigation of the Leia Sensory Prosthesis on Gait and Balance in Peripheral Neuropathy.

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Device: Active wearable device; Device: Sham wearable device

Detailed Description

This clinical investigation will assess a non-invasive wearable device designed to enhance gait and balance in individuals with peripheral neuropathy. The study will evaluate whether the device can improve balance and gait stability during daily activities, and will also examine safety, comfort, and overall user acceptability over the study period.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Meyrin, Switzerland, 1217
    • Not yet recruiting
    • Hôpital de la Tour
    • Principal Investigator: Christophe Perruchoud, PD Dr.
    • Contact: Christophe Perruchoud, PD Dr.; Phone Number: +41 22 719 65 77; Email: christophe.perruchoud@latour.ch
  • Morges, Switzerland, 1110
    • Recruiting
    • Ensemble Hospitalier de la Côte (EHC)
    • Contact: Massimo Allegri, Dr.; Phone Number: +41 21 804 27 85; Email: massimo.allegri@ehc.vd.ch
    • Principal Investigator: Massimo Allegri, Dr.
  • Zurich, Switzerland, 8008
    • Not yet recruiting
    • Universitätsklinik Balgrist
    • Contact: Carl Zipser, PD Dr. med.; Phone Number: +41 44 386 3901; Email: zfp@balgrist.ch
    • Principal Investigator: Patrick Freund, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Device; Participants use the active wearable device during the study period.	Device: Active wearable device; A non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy.
Sham Comparator: Sham Device; Participants use a sham version of the wearable device without active functionality.	Device: Sham wearable device; A sham version of the wearable device without active functionality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Gait Assessment (FGA) total score	The FGA is a validated clinical scale that assesses gait function and balance under various walking tasks. To gain additional knowledge on whether there are changes between supervised and home-use phase	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	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.	Change from Baseline to day 56
Neuropathic pain symptoms (NPSI questionnaire)	Captures changes in neuropathic pain intensity and quality.	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)	Evaluates impact of intervention on daily function and well-being.	Change from baseline to day 28, day 56 and day 80
Sensory function - Monofilament test	Sensitivity to pressure and touch	Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28 and 56)
Sensory function - Rydel-Seiffer tuning fork test	Semiquantitative measurement of vibration perception	Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28, and 56)
Sensory function - Sudoscan (subset of patients)	Evaluates peripheral sensory function and small-fiber integrity.	Change from baseline to day 56
Impact on fall risk: fall questionnaire	Assessment of previous falls and falls during the study	Change from baseline to day 28, day 56 and day 80
Neuroimaging (MRI) (subset of patients)	Exploratory mechanistic endpoint assessing effects of stimulation.	Change from baseline to day 56
Treatment compliance	Based on the device logs that contain information on when treatment has been performed by the patients, patient's treatment compliance will be assessed.	Through home use phase of 4 weeks
Objective gait parameters (Movement Lab): step length in cm	Provides quantitative kinematic evidence of gait stability.	Baseline, day 28 and day 56
Objective gait parameters (Movement Lab): step width in cm	Provides quantitative kinematic evidence of gait stability.	Baseline, day 28 and day 56
Objective gait parameters (Movement Lab): center of mass sway in cm	Provides quantitative kinematic evidence of gait stability.	Baseline, day 28 and day 56
Objective gait parameters (Movement Lab): heel-strike force in Newton	Provides quantitative kinematic evidence of gait stability.	Baseline, day 28 and day 56

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory - Sensory function - Temperature measurement using the thermal imaging camera	Temperature distribution in the feet)	Change from baseline value from day 7 prestimulation to follow-up time points day 28 and 56
Safety Outcome	All Adverse events (AEs): incidence, severity, seriousness, relatedness to device/procedures	through study completion, an average of 4 months
Safety Outcome	All Device deficiencies: number, type, corrective actions	through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: MYNERVA AG

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 (Actual): June 3, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 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-L001-001; Unique Device Identifiers (Other Identifier: GS1)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No