Technical and Clinical Validation of the WPM-SEMG Prototype

ConditionNeuron Disease, Motor

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAlain Kaelin

About this trial

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

This trial accepts healthy volunteers

Qualifiers

* Healthy volunteers

Female or male

18 years or older

Preserved cognitive capacity

Disqualifiers

Skin lesions in the area below the electrode

Allergy to metal alloys

History of skin disease

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

WPM-SEMG prototype
Device
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

Treatment groups

70 Participants

are divided into 1 treatment group

Group A: Muscle electrophysiological signals recordingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Technical and clinical assessment

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).

Time frame

Intervention (day0)

Secondary outcomes

Pain assessment

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').

Time frame

Intervention (day0)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alain Kaelin

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution

University of Applied Sciences and Arts of Southern Switzerland

Collaborator

Clinical Trial Unit Ente Ospedaliero Cantonale