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

November 22, 2025 updated by: MYNERVA AG

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

Not yet recruiting

Conditions

Intervention / Treatment

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
    • Willingness and ability to attend weekly sessions, perform home use, and return for follow-up.

Exclusion Criteria:

  • Age < 18 years at the time of consent.
  • Active foot ulcer, infection, or severe dermatological condition at electrode contact sites.
  • Cognitive impairment that precludes informed consent or device use.
  • Implanted electrical devices or pacemakers.
  • Pregnancy
  • Usage of other medical devices for the relief of neuropathic symptoms during the trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Change From Baseline in Functional Gait Assessment (FGA) Total Score
Time Frame: 2 months
Change in Functional Gait Assessment (FGA) total score (0-30 points) from baseline to 2 months. Higher scores indicate better gait and balance performance.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MYNERVA AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

April 1, 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 (Estimated)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 22, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC.01312:1
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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