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

N/ANot Yet RecruitingNCT07236515

MYNERVA AG80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Peripheral Neuropathy

Interventions

Active wearable deviceDEVICE

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

Sham wearable deviceDEVICE

A sham version of the wearable device without active functionality.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change From Baseline in Functional Gait Assessment (FGA) Total Score

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

Time frame: 2 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.