Neuron Disease, Motor
Conditions
Brief summary
Validation study designed to demonstrate the technical and clinical performance, and the safety of a new medical device in healthy volunteers and patients with myopathy or neuropathy. The medical device is the WPM-SEMG prototype designed for recording electrophysiological signals of muscles.
Detailed description
The study consists of two parts: * the first part concerns the technical validation of the prototype. It will enrol 10 healthy volunteers (Technical Validation Group). * the second part concerns the clinical validation of the prototype in comparison with the gold standard, that is the needle-EMG. It will enrol 50 healthy volunteers (Clinical Validation Group), including also the 10 subjects of the Technical Validation Group, and 20 patients Measurements will be done on 4 muscles with the WPM-SEMG device prototype using a rigid electrode matrix. For each muscle, the participant will execute some spontaneous motor activities and measurements will be taken on the muscle under tension (low, medium, and high) for a total of 12 measurements. Measurements will be repeated two times after a pause for a total of 24 acquisitions. For the group with myopathies an additional fifth muscle, not foreseen by the protocol, can be done if considered the clinical most affected muscle followingthe neurological examination. A control intervention is done on the same subjects and consists in a needle-EMG which will be applied as for routine clinical practice on the same muscles used for the WPM-SEMG device prototype. Measurements will be taken for each muscles as for the rigid matrix.
Interventions
DEVICEWPM-SEMG prototype
Measurements will be done with the rigid matrix. The flexible electrode matrix will be used only on a lower percentage of volunteers depending on the results obtained with the rigid matrix
Sponsors
University of Applied Sciences and Arts of Southern Switzerland
Clinical Trial Unit Ente Ospedaliero Cantonale
Alain Kaelin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Each participant will undergo to the study intervention and the control intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Eligibility criteria for healthy volunteers * Inclusion Criteria * Healthy volunteers * Female or male * 18 years or older * Preserved cognitive capacity * Ability to understand the study * Willingness to complete all the study assessments * No chronic or concomitant use of medications or treatment * Written informed consent *
Exclusion criteria
* Skin lesions in the area below the electrode * Allergy to metal alloys * History of skin disease * Pregnancy * Lactation * Known causes of neuromuscular disease * Inability to follow the procedures of the study Eligibility criteria for patients * Inclusion Criteria * Patients of the Neurocentro della Svizzera Italiana with diagnosis of myopathy or neuropathy that requires a needle-EMG electrophysiological testing as standard clinical management of the disease * Female or male * 18 years or older * Preserved cognitive capacity * Ability to understand the study * Willingness to complete all the study assessments * No chronic or concomitant use of medications or treatment that may influence the measure in the opinion of the investigator (muscle relaxant such as baclofen, statin, benzodiazepine). * Written informed consent *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical and clinical assessment | Intervention (day0) | Correlation between the properties of the final electrophysiological output identified from sEMG signals acquired with the WPM-SEMG device prototype and the properties of the final electrophysiological output identified from EMG signals acquired using needle EMG. \[Time Frame: Intervention (day0)\] The following properties will be extracted: Amplitude (microVolts), phases/turns (ratio), signal frequency (Hz) and duration (seconds). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | Intervention (day0) | Pain assessment during the measurements using the Visual Analog Scale (VAS). The VAS consists on a 0-10 scale, with two end points representing 0 ('no pain') and 10 ('worst possible pain'). |
Countries
Switzerland
Contacts
Primary ContactAlain Kaelin, Prof.
Backup ContactManuela Maffongelli
Outcome results
None listed