Technical and Clinical Validation of the WPM-SEMG Prototype

Technical and Clinical Validation Study of a New Wireless Portable and Multi-Channel Surface EMG Device to Analyse Motor Unit Action Potentials

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.

Study Overview

• Status: Recruiting
• Conditions: Neuron Disease, Motor
• Intervention / Treatment: Device: WPM-SEMG prototype

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alain Kaelin, Prof.; Phone Number: +41 (0)91 811 62 57; Email: alain.kaelin@eoc.ch
• Study Contact Backup: Name: Manuela Maffongelli; Phone Number: +41 (0)58 666 65 41; Email: manuela.maffongelli@supsi.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • Neurocentro della Svizzera Italiana
    • Contact: Alain Kaelin, Prof; Phone Number: +41 (0)91 811 62 57; Email: alain.kaelin@eoc.ch
    • Contact: Claudio Gobbi, MD; Phone Number: +41 (0)91 811 69 21; Email: claudio.gobbi@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscle electrophysiological signals recording; Recording of electrophysiological signals of muscles with a WPM-SEMG prototype	Device: WPM-SEMG prototype; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Intervention (day0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Pain assessment during the measurements done with a pain scale from 1 to 10 (VAS)	Intervention (day0)

Collaborators and Investigators

• Sponsor: Alain Kaelin
• Collaborators: University of Applied Sciences and Arts of Southern Switzerland; Clinical Trial Unit Ente Ospedaliero Cantonale

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2018
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Motor Neuron Disease
• Other Study ID Numbers: SUPSI-2017-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No