Can a High-Tech wearable steady the steps of nerve damage patients?
NCT ID NCT07236515
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
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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
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Ensemble Hospitalier de la Côte (EHC)
RECRUITINGMorges, 1110, Switzerland
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Hôpital de la Tour
NOT_YET_RECRUITINGMeyrin, 1217, Switzerland
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Universitätsklinik Balgrist
NOT_YET_RECRUITINGZurich, 8008, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Cold therapy may offer relief for Chemotherapy-Induced nerve pain in children
- Could a simple blood test track nerve damage? a study investigates NT-3 levels in neuropathy.
- Wearable insoles warn of foot pressure to stop diabetic ulcers
- New bladder cancer drug aims to fight tumors without harming nerves
- Acupuncture with a jolt: could needles shield nerves from chemo?