Clinical trial NCT06584084: Technical and Clinical Validation of the WPM-SEMG Prototype
Official title: Technical and Clinical Validation Study of a New Wireless Portable and Multi-Channel Surface EMG Device to Analyse Motor Unit Action Potentials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuron Disease, Motor
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences and Arts of Southern Switzerland
name: Clinical Trial Unit Ente Ospedaliero Cantonale
First posted: 2024-09-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will undergo to the study intervention and the control intervention
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical and clinical assessment
timeFrame: Intervention (day0)
Secondary outcomes:
measure: Pain assessment
timeFrame: Intervention (day0)
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Neurocentro della Svizzera Italiana
Study officials:
References: