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Recruiting NCT06584084

Technical and Clinical Validation of the WPM-SEMG Prototype

No phase Interventional Neuron Disease, Motor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WPM-SEMG prototype.
Who it may be relevant to
Registry conditions: Neuron Disease, Motor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Technical and clinical assessment [Time frame: Intervention (day0)]
Secondary outcome measures (1)
  • Pain assessment [Time frame: Intervention (day0)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Switzerland · 1 center
  • Neurocentro della Svizzera Italiana — Lugano

Identifiers

NCT: NCT06584084 · SUPSI-2017-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗