Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy (MYN-L001-001)

MYNERVA AG

Status: Not yet enrolling

Conditions: Peripheral Neuropathy

Treatments: Device: Sham wearable device; Device: Active wearable device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07236515

Unique Device Identifiers (Other Identifier)

REC.01312:1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Active Device

Experimental group

Description:

Participants use the active wearable device during the study period.

Treatment:

Device: Active wearable device

Sham Device

Sham Comparator group

Description:

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

Treatment:

Device: Sham wearable device