NCT06584084 Technical and Clinical Validation of the WPM-SEMG Prototype
| NCT ID | NCT06584084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alain Kaelin |
| Condition | Neuron Disease, Motor |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2018-01-19 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2018-01-19 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06584084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuron Disease, Motor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06584084 currently recruiting?
Yes, NCT06584084 is actively recruiting participants. Contact the research team at alain.kaelin@eoc.ch for enrollment information.
Where is the NCT06584084 trial being conducted?
This trial is being conducted at Lugano, Switzerland.
Who is sponsoring the NCT06584084 clinical trial?
NCT06584084 is sponsored by Alain Kaelin. The trial plans to enroll 70 participants.