NCT07236515

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: MYNERVA AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Active wearable device	A non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy.
DEVICE	Sham wearable device	A sham version of the wearable device without active functionality.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-04-01
• Completion: 2028-08-01
• First posted: 2025-11-19
• Last updated: 2025-11-28