Status:
RECRUITING
Technical and Clinical Validation of the WPM-SEMG Prototype
Lead Sponsor:
Alain Kaelin
Collaborating Sponsors:
University of Applied Sciences and Arts of Southern Switzerland
Clinical Trial Unit Ente Ospedaliero Cantonale
Conditions:
Neuron Disease, Motor
Eligibility:
All Genders
18+ years
Phase:
NA
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 devi...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06584084
Start Date
January 19 2018
End Date
April 30 2026
Last Update
September 19 2024
Active Locations (1)
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1
Neurocentro della Svizzera Italiana
Lugano, Switzerland, 6900