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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMYNERVA AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active wearable device

    Device

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

  • Sham wearable device

    Device

    A sham version of the wearable device without active functionality.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Active DeviceExperimental treatment 1 intervention
Group B: Sham DeviceSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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