Technical and Clinical Validation of the WPM-SEMG Prototype

NCT06584084 | Recruiting

• 1 other identifier: SUPSI-2017-006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuron Disease, Motor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain assessment

  Intervention (day0)

Study Arms (1)

Muscle electrophysiological signals recording

EXPERIMENTAL

Recording of electrophysiological signals of muscles with a WPM-SEMG prototype

Device: WPM-SEMG prototype

Interventions

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

Muscle electrophysiological signals recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Female or male
• 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

You may not qualify if:

• 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
• 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
• 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).

Sponsors & Collaborators

• Alain Kaelin: lead
• University of Applied Sciences and Arts of Southern Switzerland: collaborator
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (1)

Neurocentro della Svizzera Italiana

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Motor Neuron Disease

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Central Study Contacts

Alain Kaelin, Prof.

CONTACT

+41 (0)91 811 62 57; alain.kaelin@eoc.ch

Manuela Maffongelli

CONTACT

+41 (0)58 666 65 41; manuela.maffongelli@supsi.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: Each participant will undergo to the study intervention and the control intervention

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: September 4, 2024
• Study Start: January 19, 2018
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CH (1)