Technical and Clinical Validation of the WPM-SEMG Prototype

Not Applicable

Recruiting

• Conditions: Neuron Disease, Motor
• Interventions: Device: WPM-SEMG prototype

• Registration Number: NCT06584084
• Lead Sponsor: Alain Kaelin

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.

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 clinical validation of the prototype in comparison with the gold standard, that is the needle-EMG. It will enrol 50 healthy volunteers (Clinical Validation Group), including also the 10 subjects of the Technical Validation Group, and 20 patients

Measurements will be done on 4 muscles with the WPM-SEMG device prototype using a rigid electrode matrix. For each muscle, the participant will execute some spontaneous motor activities and measurements will be taken on the muscle under tension (low, medium, and high) for a total of 12 measurements. Measurements will be repeated two times after a pause for a total of 24 acquisitions. For the group with myopathies an additional fifth muscle, not foreseen by the protocol, can be done if considered the clinical most affected muscle followingthe neurological examination.

A control intervention is done on the same subjects and consists in a needle-EMG which will be applied as for routine clinical practice on the same muscles used for the WPM-SEMG device prototype. Measurements will be taken for each muscles as for the rigid matrix.

Study Timeline

• Study Start: 2018-01-19
• Study First Submitted: 2018-01-23
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muscle electrophysiological signals recording	WPM-SEMG prototype	Recording of electrophysiological signals of muscles with a WPM-SEMG prototype

Primary Outcome Measures

Name	Time	Method
Technical and clinical assessment	Intervention (day0)	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).

Secondary Outcome Measures

Name	Time	Method
Pain assessment	Intervention (day0)	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').

Trial Locations

Locations (1)

Neurocentro della Svizzera Italiana; 🇨🇭 Lugano, Switzerland