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Can a High-Tech wearable steady the steps of nerve damage patients?

NCT ID NCT07236515

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study tests a wearable device called the Leia sensory prosthesis in 80 adults with peripheral neuropathy, a condition that often causes balance problems and unsteady walking. Participants will either use the active device or a sham version for two months. The main goal is to see if the device improves gait and balance, as measured by a standard walking test.

What this could mean

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

Active substance
wearable sensory prosthesis device
What this could lead to
If it works, this could provide a non-invasive way to help people with peripheral neuropathy walk more steadily and reduce fall risk.
What could go wrong
This is an early-stage trial with only 80 participants, and the device is compared to a sham version, so the real benefit may be small or absent. It also requires regular clinic visits and home use, which may not suit everyone.

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 80 people

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

Started

Jun 2026

Expected to finish

Aug 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 and neurophysiological testing (e.g. NCV) * Gait or balance difficulties as self-reported and confirmed by Functional Gait Assessment (FGA score ≤ 23) and/or single-leg stance \< 30 seconds * Able to walk without walking aids * Stable supplements and medications ≥ 1 month before baseline and willing to maintain stability during the investigation (same dosage and same medication within the last month) * Willingness and ability to attend weekly sessions, perform home use, and return for follow-up Exclusion Criteria: * Untreated/unhealed lesion of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near product 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) * Cognitive impairment that precludes informed consent or device use * 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 * For patients who have been randomized in the active treatment group only: Incapability to perceive somatotopic sensations (tested at screening by MYNERVA staff)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Ensemble Hospitalier de la Côte (EHC)

    RECRUITING

    Morges, 1110, Switzerland

  • Hôpital de la Tour

    NOT_YET_RECRUITING

    Meyrin, 1217, Switzerland

  • Universitätsklinik Balgrist

    NOT_YET_RECRUITING

    Zurich, 8008, Switzerland

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