Actively Recruiting
Technical and Clinical Validation of the WPM-SEMG Prototype
Led by Alain Kaelin · Updated on 2024-09-19
70
Participants Needed
1
Research Sites
431 weeks
Total Duration
On this page
Sponsors
A
Alain Kaelin
Lead Sponsor
U
University of Applied Sciences and Arts of Southern Switzerland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Technical and Clinical Validation of the WPM-SEMG Prototype
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Patients with diagnosis of myopathy or neuropathy requiring needle-EMG testing
- No chronic or concomitant use of medications or treatment that may influence the measure in the opinion of the investigator (e.g., muscle relaxants, statin, benzodiazepine)
You will not qualify if you...
- Skin lesions in the area below the electrode
- Allergy to metal alloys
- History of skin disease
- Pregnancy
- Lactation
- Known causes of neuromuscular disease (for healthy volunteers)
- Cognitive and/or psychiatric disorders (for patients)
- Neuromuscular disease other than myopathy and neuropathy (for patients)
- Inability to follow the procedures of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Neurocentro della Svizzera Italiana
Lugano, Switzerland, 6900
Actively Recruiting
Research Team
A
Alain Kaelin, Prof.
CONTACT
M
Manuela Maffongelli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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