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

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

Treatments tested in this trial

  • Active wearable device
  • Sham wearable device

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators