Peripheral NeuropathyMYN-L001-001NCT07236515
Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy
A study testing Active wearable device in people with Peripheral Neuropathy, run by MYNERVA AG at 3 sites in Switzerland.
Trial 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. 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?
- Active wearable device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 3 Jun 2026to 1 Aug 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 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Not yet recruiting
Hôpital de la Tour
Meyrin, 1217
Christophe Perruchoud, PD Dr., +41 22 719 65 77, christophe.perruchoud@latour.ch
Christophe Perruchoud, PD Dr.
- Recruiting
Ensemble Hospitalier de la Côte (EHC)
Morges, 1110
Massimo Allegri, Dr., +41 21 804 27 85, massimo.allegri@ehc.vd.ch
Massimo Allegri, Dr.
- Not yet recruiting
Universitätsklinik Balgrist
Zurich, 8008
Carl Zipser, PD Dr. med., +41 44 386 3901, zfp@balgrist.ch
Patrick Freund, Prof. Dr. med.
About this study
Official title: Randomized, Sham-Controlled, Multicenter Investigation of the Leia Sensory Prosthesis on Gait and Balance in Peripheral Neuropathy.
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.
Read the detailed description
This clinical investigation will assess a non-invasive wearable device designed to enhance gait and balance in individuals with peripheral neuropathy. The study will evaluate whether the device can improve balance and gait stability during daily activities, and will also examine safety, comfort, and overall user acceptability over the study period.
- Conditions
- Peripheral Neuropathy
- Being tested
- Active wearable device, Sham wearable device
- 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.
Active wearable deviceDevice
A non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy.
Sham wearable deviceDevice
A sham version of the wearable device without active functionality.
| Study group | Role | What they receive |
|---|---|---|
| Active Device | Experimental | Participants use the active wearable device during the study period. Receives: Device: Active wearable device |
| Sham Device | Sham comparator | Participants use a sham version of the wearable device without active functionality. Receives: Device: Sham wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Gait Assessment (FGA) total score
The FGA is a validated clinical scale that assesses gait function and balance under various walking tasks.
Measured: Change in Functional Gait Assessment (FGA) total score from baseline (day 0) to day 56.
Secondary outcomes (14)
Functional Gait Assessment (FGA) total score
The FGA is a validated clinical scale that assesses gait function and balance under various walking tasks. To gain additional knowledge on whether there are changes between supervised and home-use phase
Measured: From baseline (day 0) to the end of the supervised period (day 28), change from day 28 to day 56, and evaluation of evolution across all timepoints, with and without stimulation
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: Change from Baseline to day 56
Neuropathic pain symptoms (NPSI questionnaire)
Captures changes in neuropathic pain intensity and quality.
Measured: Change from baseline to each of the follow-up time points (day 7, 14, 28, 35, 42, 49, 56 and 80)
Quality of life (NORFOLK QOL-DN, EQ-5D-5L questionnaire)
Evaluates impact of intervention on daily function and well-being.
Measured: Change from baseline to day 28, day 56 and day 80
Sensory function - Monofilament test
Sensitivity to pressure and touch
Measured: Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28 and 56)
Sensory function - Rydel-Seiffer tuning fork test
Semiquantitative measurement of vibration perception
Measured: Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28, and 56)
Sensory function - Sudoscan (subset of patients)
Evaluates peripheral sensory function and small-fiber integrity.
Measured: Change from baseline to day 56
Impact on fall risk: fall questionnaire
Assessment of previous falls and falls during the study
Measured: Change from baseline to day 28, day 56 and day 80
Neuroimaging (MRI) (subset of patients)
Exploratory mechanistic endpoint assessing effects of stimulation.
Measured: Change from baseline to day 56
Treatment compliance
Based on the device logs that contain information on when treatment has been performed by the patients, patient's treatment compliance will be assessed.
Measured: Through home use phase of 4 weeks
Objective gait parameters (Movement Lab): step length in cm
Provides quantitative kinematic evidence of gait stability.
Measured: Baseline, day 28 and day 56
Objective gait parameters (Movement Lab): step width in cm
Provides quantitative kinematic evidence of gait stability.
Measured: Baseline, day 28 and day 56
Objective gait parameters (Movement Lab): center of mass sway in cm
Provides quantitative kinematic evidence of gait stability.
Measured: Baseline, day 28 and day 56
Objective gait parameters (Movement Lab): heel-strike force in Newton
Provides quantitative kinematic evidence of gait stability.
Measured: Baseline, day 28 and day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start3 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Aug 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, sham-controlled, multicenter.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MYNERVA AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236515
- Sponsor's protocol ID
- MYN-L001-001
- Other IDs
- Unique Device Identifiers
- Acronym
- MYN-L001-001
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Sham-Controlled, Multicenter Investigation of the Leia Sensory Prosthesis on Gait and Balance in Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT07236515
- Acronym / sponsor ID
- MYN-L001-001 / MYN-L001-001
- Conditions
- Peripheral Neuropathy
- Keywords
- Peripheral neuropathy, Sensory Prosthesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- MYNERVA AGIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 19 Nov 2025 (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 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.
Detailed description
This clinical investigation will assess a non-invasive wearable device designed to enhance gait and balance in individuals with peripheral neuropathy. The study will evaluate whether the device can improve balance and gait stability during daily activities, and will also examine safety, comfort, and overall user acceptability over the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, sham-controlled, multicenter.
| Arm | Type | Receives |
|---|---|---|
| Active Device | Experimental | Device: Active wearable deviceParticipants use the active wearable device during the study period. |
| Sham Device | Sham comparator | Device: Sham wearable deviceParticipants use a sham version of the wearable device without active functionality. |
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 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Active wearable deviceA non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy. | Device | Active Device |
| Sham wearable deviceA sham version of the wearable device without active functionality. | Device | Sham Device |
Primary outcome
Functional Gait Assessment (FGA) total score
Time frame: Change in Functional Gait Assessment (FGA) total score from baseline (day 0) to day 56.
The FGA is a validated clinical scale that assesses gait function and balance under various walking tasks.
14 secondary outcomes
Functional Gait Assessment (FGA) total score
Time frame: From baseline (day 0) to the end of the supervised period (day 28), change from day 28 to day 56, and evaluation of evolution across all timepoints, with and without stimulation
Timed-up and Go (TUG) in seconds
Time frame: Change from Baseline to day 56
Neuropathic pain symptoms (NPSI questionnaire)
Time frame: Change from baseline to each of the follow-up time points (day 7, 14, 28, 35, 42, 49, 56 and 80)
Quality of life (NORFOLK QOL-DN, EQ-5D-5L questionnaire)
Time frame: Change from baseline to day 28, day 56 and day 80
Sensory function - Monofilament test
Time frame: Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28 and 56)
Sensory function - Rydel-Seiffer tuning fork test
Time frame: Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28, and 56)
Sensory function - Sudoscan (subset of patients)
Time frame: Change from baseline to day 56
Impact on fall risk: fall questionnaire
Time frame: Change from baseline to day 28, day 56 and day 80
Neuroimaging (MRI) (subset of patients)
Time frame: Change from baseline to day 56
Treatment compliance
Time frame: Through home use phase of 4 weeks
Objective gait parameters (Movement Lab): step length in cm
Time frame: Baseline, day 28 and day 56
Objective gait parameters (Movement Lab): step width in cm
Time frame: Baseline, day 28 and day 56
Objective gait parameters (Movement Lab): center of mass sway in cm
Time frame: Baseline, day 28 and day 56
Objective gait parameters (Movement Lab): heel-strike force in Newton
Time frame: Baseline, day 28 and day 56
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 15 Jul 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.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active wearable device in people with Peripheral Neuropathy, run by MYNERVA AG at 3 sites in Switzerland.
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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Gait Assessment (FGA) total score (time frame: Change in Functional Gait Assessment (FGA) total score from baseline (day 0) to day 56.). 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 NCT07236515, 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 15 Jul 2026.