Validation of a new medical device for recording muscle signals
Technical and Clinical Validation Study of a New Wireless Portable and Multi-Channel Surface EMG Device to Analyse Motor Unit Action Potentials
This study is testing a new device that records muscle signals to see if it works as well as the standard method in both healthy people and those with muscle or nerve conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT06584084 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the technical and clinical performance of the WPM-SEMG prototype, a new medical device designed to record electrophysiological signals from muscles. It consists of two parts: the first part involves technical validation with 10 healthy volunteers, while the second part includes clinical validation comparing the prototype to the gold standard needle-EMG in 50 healthy volunteers and 20 patients with myopathy or neuropathy. Measurements will be taken on multiple muscles during various activities to assess the device's effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with myopathy or neuropathy who require needle-EMG testing as part of their clinical management.
Not a fit: Patients with skin lesions in the electrode area, known neuromuscular diseases, or those unable to follow study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a safer and more efficient method for assessing muscle function in patients with neuromuscular diseases.
How similar studies have performed: While the approach of using a prototype device for muscle signal recording is innovative, similar studies have shown promise in validating new electrophysiological assessment tools.
Eligibility criteria
Show full inclusion / exclusion 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 * Exclusion Criteria * Skin lesions in the area below the electrode * Allergy to metal alloys * History of skin disease * Cognitive and/or psychiatric disorders * Pregnancy * Lactation * Neuromuscular disease other than myopathy and neuropathy * Inability to follow the procedures of the study
Where this trial is running
Lugano
- Neurocentro della Svizzera Italiana — Lugano, Switzerland (Recruiting)
Study contacts
- Study coordinator: Alain Kaelin, Prof.
- Email: alain.kaelin@eoc.ch
- Phone: +41 (0)91 811 62 57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.