Peripheral NeuropathyMYN-L001-002NCT07840157
A Mixed-Methods Exploratory Pilot Study of the Investigational MYNERVA Leia Sensory Prosthesis in U.S. Adults With Peripheral Neuropathy
A study testing Leia Sensory Prosthesis in people with Peripheral Neuropathy, run by Mynerva Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Leia Sensory Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Foot Specialists of South Mississippi
Ocean Springs, Mississippi, 39564
About this study
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.
Read the detailed description
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.
- Conditions
- Peripheral Neuropathy
- Being tested
- Leia Sensory Prosthesis
- Keywords
- Peripheral neuropathy, Sensory Prosthesis
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leia Sensory ProsthesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Leia Sensory Prosthesis | Experimental | Participants use the device during a single supervised session at the clinic Receives: Device: Leia Sensory Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait parameters
using the 10-meter walking test
Measured: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At visit 1 (Day 1)
Fall history: fall questionnaire
Assessment of previous falls
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At visit 1 (Day 1) during the single 30 minutes treatment session until the maximal 6 months follow-up period ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start18 Sep 2026 (estimated)
- Primary completion18 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mynerva Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840157
- Sponsor's protocol ID
- MYN-L001-002
- Other IDs
- Unique Device Identifiers
- Acronym
- MYN-L001-002
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gozzi N, Chee L, Odermatt I, Kikkert S, Preatoni G, Valle G, Pfender N, Beuschlein F, Wenderoth N, Zipser C, Raspopovic S. Wearable non-invasive neuroprosthesis for targeted sensory restoration in neuropathy. Nat Commun. 2024 Dec 30;15(1):10840. doi: 10.1038/s41467-024-55152-7.
PubMed 39738088
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-Methods Exploratory Pilot Study of the Investigational MYNERVA Leia Sensory Prosthesis in U.S. Adults With Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07840157
- Acronym / sponsor ID
- MYN-L001-002 / MYN-L001-002
- Conditions
- Peripheral Neuropathy
- Keywords
- Peripheral neuropathy, Sensory Prosthesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mynerva Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- 18 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leia Sensory Prosthesis | Experimental | Device: Leia Sensory ProsthesisParticipants use the device during a single supervised session at the clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leia Sensory ProsthesisA 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. | Device | Leia Sensory Prosthesis |
Primary outcome
Change in gait parameters
Time frame: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
using the 10-meter walking test
12 secondary outcomes
Single-leg stance
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
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
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)
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
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)
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
Time frame: At visit 1 (Day 1)
Fall history: fall questionnaire
Time frame: At visit 1 (Day 1) before the intervention
Usability and patient satisfaction
Time frame: At visit 1 (Day 1) directly after the single treatment session
Patient-reported perceived clinical effects after stimulation
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
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
Time frame: At visit 1 (Day 1) during the single 30 minutes treatment session until the maximal 6 months follow-up period ends
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 39738088Gozzi N, Chee L, Odermatt I, Kikkert S, Preatoni G, Valle G, Pfender N, Beuschlein F, Wenderoth N, Zipser C, Raspopovic S. Wearable non-invasive neuroprosthesis for targeted sensory restoration in neuropathy. Nat Commun. 2024 Dec 30;15(1):10840. doi: 10.1038/s41467-024-55152-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leia Sensory Prosthesis in people with Peripheral Neuropathy, run by Mynerva Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait parameters (time frame: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07840157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.