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

NCT07236515 | Not Yet Recruiting DMC

• 2 other identifiers: REC.01312:1Unique Device Identifiers
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Neuropathy

Keywords

Peripheral neuropathy; Sensory Prosthesis

Outcome Measures

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.

  2 months

Study Arms (2)

Active Device

EXPERIMENTAL

Participants use the active wearable device during the study period.

Device: Active wearable device

Sham Device

SHAM COMPARATOR

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

Device: Sham wearable device

Interventions

Active wearable device DEVICE

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

Active Device

Sham wearable device DEVICE

A sham version of the wearable device without active functionality.

Sham Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MYNERVA AG: lead

Related Publications (1)

• 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.

  PMID: 39738088 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessors are masked to group allocation (active vs. sham).A subset of care providers responsible for device setup and allocation is unblinded due to practical requirements, while other care providers interacting with participants remain blinded whenever feasible. Investigators at the site have access to allocation information if needed for safety or clinical decision-making.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, sham-controlled, multicenter.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11