An interventional study of Leia Sensory Prosthesis in Peripheral Neuropathy, sponsored by Mynerva Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Mynerva Inc. · Not applicable, Interventional, and Treatment
Among 191 studies in Peripheral Nervous System Diseases with a site in United States — 31 open to participants now, 48 under way, 2 of them phase 3. Peripheral Nervous System Diseases · United States.
Among the 191 studies in Peripheral Nervous System Diseases with a site in United States, this one is the 33rd largest by planned enrollment of the 157 interventional ones that give a count, is one of 13 that started in 2026, is one of 91 with no phase, reaches primary completion later than 28 of the 46 other live ones, and was the 191st registered.
476 studies on the registry are indexed under Peripheral Nervous System Diseases; 103 are open to participants now.
Browse Peripheral Nervous System Diseases studies →31 of the 191 studies in Peripheral Nervous System Diseases with a site in United States are open now. Recruiting first, the newest first:
Dana-Farber Cancer Institute · Sites in United States
Montefiore Medical Center · Sites in United States
RxFunction Inc. · Sites in United States
Yale University · Sites in United States
Generate Biomedicines · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 65 Peripheral Nervous System Diseases studies recruiting now, 44 (68%) set no upper age limit and 10 (15%) stop at 75 or younger; 8 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
191 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 40 · Phase 3 22 · Phase 4 4
First in 1984; this study’s year is marked. 13 started in 2026.
This study's planned enrollment of 100 is above the median of 57 across 359 interventional studies indexed under Peripheral Nervous System Diseases.
Median enrollment 43 across the 157 interventional studies, 80 across the 31 observational. Of the 129 that completed or were terminated, 58 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
46 of 191 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Mynerva Inc. as lead sponsor.
Mynerva Inc. has 1 study filed under Peripheral Nervous System Diseases — fewer than ten, so there is no comparison to draw.
21 of the studies in Peripheral Nervous System Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06848348Dogwood Therapeutics Inc.Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain | 2026-12 |
| NCT04865679Axogen CorporationTolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends | 2026-12 |
| NCT07674420Johns Hopkins UniversityWearable Insoles for Recurrent Diabetic Ulcer Prevention | 2027-01 |
| NCT04800484University of IowaThe Effects of AFO Heel Height and Stiffness on Gait | 2027-01-01 |
| NCT03584022Mayo ClinicClinical Trial to Assess the Safety of a Novel Scaffold Biomaterial | 2027-03 |
Among the 191 studies in Peripheral Nervous System Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a US-specific pilot study to evaluate the short- and long-term effects of the investigational MYNERVA Leia Sensory Prosthesis on gait, neuropathic symptoms and quality of life in US adults with peripheral neuropathy, and to capture insights on the device's usability and perceived clinical effects.
Through a single, two-hour in-person session per participant, this study is intended to generate preliminary evidence on whether the Leia Sensory Prosthesis improves gait patterns and sensory function in US adults with peripheral neuropathy, based on short-term device use.
A phone follow-up will inform on participant-reported clinical effects of the single use of Leia, and their duration.
Findings will also allow to gain a more comprehensive understanding of US demographic specifics to inform future device design, usability improvements, and potential adoption barriers ahead of further clinical development.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants use the device during a single supervised session at the clinic
Device: Leia Sensory Prosthesis
A non-invasive wearable device used to evaluate the short- and long-term effects on gait, neuropathic symptoms and quality of life in US adults with peripheral neuropathy, and to capture insights on the device's usability and perceived clinical effects.
Change in gait parameters
using the 10-meter walking test
Time frame: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
Single-leg stance
The single-leg stance test is a simple clinical assessment used to evaluate static balance and postural control. The patient is instructed to stand unassisted on one leg for up to 30 seconds, with eyes open and arms by the side. The test is performed in both legs. Inability to maintain the position for 30 seconds indicating impaired balance and increased risk of falls.
Time frame: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
Timed-up and Go (TUG) in seconds
The Timed Up and Go (TUG) test assesses functional mobility. Participants are instructed to stand up from a chair, walk 3 metres at their usual pace, turn around, walk back to the chair, and sit down. The time from the command to start until the participant is seated again is recorded in seconds. A shorter time indicates better functional mobility.
Time frame: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
Sensory function - Monofilament test
Sensitivity to pressure and touch
Time frame: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) directly after the single 30 minutes treatment session
Quality of life (NORFOLK QOL-DN (in part)
Evaluates impact of intervention on daily function and well-being.
Time frame: At visit 1 (Day 1) before the intervention, 1 day after intervention (visit 2), monthly up to max. 6 months (only if patients perceived persisting benefit)
EQ-5D (in part) questionnaire
Evaluates impact of intervention on daily function and well-being.
Time frame: At visit 1 (Day 1) before the intervention, 1 day after intervention (visit 2), monthly up to max. 6 months (only if patients perceived persisting benefit)
Neuropathic pain symptoms (NPSI questionnaire)
Captures changes in neuropathic pain intensity and quality.
Time frame: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) directly after the single 30 minutes treatment session
Patient history including symptoms, patient journey, and treatments received related to peripheral neuropathy
Patients are asked for their symptoms, disease progression, diagnostic pathway and treatments received related to peripheral neuropathy
Time frame: At visit 1 (Day 1)
Fall history: fall questionnaire
Assessment of previous falls
Time frame: At visit 1 (Day 1) before the intervention
Usability and patient satisfaction
Patients will provide feedback on usability, comfort and user-friendliness in a patient satisfaction questionaire.
Time frame: At visit 1 (Day 1) directly after the single treatment session
Patient-reported perceived clinical effects after stimulation
Patients are asked for perceived clinical effect after stimulation via phone call follow-up
Time frame: 1 day after intervention (visit 2), monthly until the effect is not persisting anymore or latest at 6 monts (whatever occurrs first)
Safety Outcome
All Adverse events (AEs): incidence, severity, seriousness, relatedness to device/procedures
Time frame: At visit 1 (Day 1) during the single 30 minutes treatment session until the maximal 6 months follow-up period ends
Safety Outcome
All Device deficiencies: number, type, corrective actions
Time frame: At visit 1 (Day 1) during the single 30 minutes treatment session until the maximal 6 months follow-up period ends
Plan to share: No
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 132 interventional studies with no phase under Peripheral Nervous System Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases →