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Can a wearable device steady the walk of Nerve-Damaged feet?

NCT ID NCT07840157

Symptom relief Sponsor: Mynerva Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

Researchers are testing an investigational wearable device called the MYNERVA Leia Sensory Prosthesis in U.S. adults with peripheral neuropathy. The pilot study aims to see how the device affects walking, balance, neuropathic symptoms, and quality of life over the short and long term. About 100 participants will use the device and provide feedback on how easy it is to use and whether they notice any changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a wearable sensory prosthesis called the MYNERVA Leia
What this could lead to
If it works, this could offer a non-invasive way to help people with peripheral neuropathy walk more steadily and feel more stable on their feet.
What could go wrong
This is an early pilot study with about 100 participants, so any benefits seen may not hold up in larger trials. The device may not help everyone, and some people may find it uncomfortable or hard to use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent prior to any study procedure * Adults ≥ 18 years * Clinical diagnosis of peripheral neuropathy, confirmed per site procedures * Gait or balance difficulties as self-reported and confirmed by single-leg stance \< 30 seconds * Able to walk without walking aids * Stable supplements and medications ≥ 1 month before intervention and willing to maintain stability during 1 month following the intervention * Willingness and ability to attend the initial in-person session (up to 2 hours) and follow-up calls. Exclusion Criteria: * Untreated/unhealed lesions of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near device use (e.g., untreated lymphedema, phlebitis, thrombo-phlebitis or varicose veins) * Untreated/unhealed fractures in the foot and ankle * Cancerous growth in the planned treatment area * Severe peripheral vascular disease (e.g., gangrene) * Implanted electrical devices or pacemakers * Lower-limb orthoses/braces that cannot be removed for assessments * Pregnant or breast-feeding females * Usage of other medical devices for the relief of neuropathic symptoms during the study * Current participation in any other clinical study using an investigational device or investigational drug * Orthopedic conditions substantially limiting gait (e.g., failed back surgery syndrome (FBSS), recent hip or knee replacement, unstable fractures) as judged by the investigator * Inability to perceive the stimulation (tested by MYNERVA staff during calibration) * Cognitive impairment or poor command of English that preclude informed consent or answering questionnaires

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Conditions

The condition(s) this trial relates to.

peripheral nervous system disorder peripheral neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral neuropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Foot Specialists of South Mississippi

    Ocean Springs, Mississippi, 39564, United States

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