NCT07236515 Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy
| NCT ID | NCT07236515 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MYNERVA AG |
| Condition | Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-06-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-06-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Frequently Asked Questions
Who can join the NCT07236515 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07236515 currently recruiting?
Yes, NCT07236515 is actively recruiting participants. Visit ClinicalTrials.gov or contact MYNERVA AG to inquire about joining.
Where is the NCT07236515 trial being conducted?
This trial is being conducted at Meyrin, Switzerland, Morges, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT07236515 clinical trial?
NCT07236515 is sponsored by MYNERVA AG. The trial plans to enroll 80 participants.