Peripheral Neuropathy
Conditions
Keywords
Peripheral neuropathy, Sensory Prosthesis
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.
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.
Interventions
DEVICEActive wearable device
A non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy.
DEVICESham wearable device
A sham version of the wearable device without active functionality.
Sponsors
MYNERVA AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants and outcomes assessors are masked to group allocation (active vs. sham). A subset of care providers responsible for device setup and allocation is unblinded due to practical requirements, while other care providers interacting with participants remain blinded whenever feasible. Investigators at the site have access to allocation information if needed for safety or clinical decision-making.
Intervention model description
Randomized, sham-controlled, multicenter.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Gait Assessment (FGA) total score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Gait Assessment (FGA) total score | 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 | 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 |
| Timed-up and Go (TUG) in seconds | Change from Baseline to day 56 | 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. |
| Neuropathic pain symptoms (NPSI questionnaire) | Change from baseline to each of the follow-up time points (day 7, 14, 28, 35, 42, 49, 56 and 80) | Captures changes in neuropathic pain intensity and quality. |
| Quality of life (NORFOLK QOL-DN, EQ-5D-5L questionnaire) | Change from baseline to day 28, day 56 and day 80 | Evaluates impact of intervention on daily function and well-being. |
| Sensory function - Monofilament test | Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28 and 56) | Sensitivity to pressure and touch |
| Sensory function - Rydel-Seiffer tuning fork test | Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28, and 56) | Semiquantitative measurement of vibration perception |
| Sensory function - Sudoscan (subset of patients) | Change from baseline to day 56 | Evaluates peripheral sensory function and small-fiber integrity. |
| Impact on fall risk: fall questionnaire | Change from baseline to day 28, day 56 and day 80 | Assessment of previous falls and falls during the study |
| Neuroimaging (MRI) (subset of patients) | Change from baseline to day 56 | Exploratory mechanistic endpoint assessing effects of stimulation. |
| Treatment compliance | Through home use phase of 4 weeks | Based on the device logs that contain information on when treatment has been performed by the patients, patient's treatment compliance will be assessed. |
| Objective gait parameters (Movement Lab): step length in cm | Baseline, day 28 and day 56 | Provides quantitative kinematic evidence of gait stability. |
| Objective gait parameters (Movement Lab): step width in cm | Baseline, day 28 and day 56 | Provides quantitative kinematic evidence of gait stability. |
| Objective gait parameters (Movement Lab): center of mass sway in cm | Baseline, day 28 and day 56 | Provides quantitative kinematic evidence of gait stability. |
| Objective gait parameters (Movement Lab): heel-strike force in Newton | Baseline, day 28 and day 56 | Provides quantitative kinematic evidence of gait stability. |
Countries
Switzerland
Outcome results
None listed