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

NCT ID: NCT07236515

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-08-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Device

Participants use the active wearable device during the study period.

Group Type: EXPERIMENTAL

Active wearable device

Intervention Type: DEVICE

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

Sham Device

Participants use a sham version of the wearable device without active functionality.

Group Type: SHAM_COMPARATOR

Sham wearable device

Intervention Type: DEVICE

A sham version of the wearable device without active functionality.

Interventions

Active wearable device

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

Intervention Type: DEVICE

Sham wearable device

A sham version of the wearable device without active functionality.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MYNERVA AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Gozzi N, Chee L, Odermatt I, Kikkert S, Preatoni G, Valle G, Pfender N, Beuschlein F, Wenderoth N, Zipser C, Raspopovic S. Wearable non-invasive neuroprosthesis for targeted sensory restoration in neuropathy. Nat Commun. 2024 Dec 30;15(1):10840. doi: 10.1038/s41467-024-55152-7.

Reference Type: BACKGROUND

PMID: 39738088 (View on PubMed)

Other Identifiers

Unique Device Identifiers

Identifier Type: OTHER

Identifier Source: secondary_id

REC.01312:1

Identifier Type: -

Identifier Source: org_study_id