Technical and Clinical Validation of the WPM-SEMG Prototype

NCT ID: NCT06584084

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-19
• Study Completion Date: 2026-04-30

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.

Conditions

Neuron Disease, Motor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Muscle electrophysiological signals recording

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

Group Type: EXPERIMENTAL

WPM-SEMG prototype

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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
• Pregnancy
• Lactation
• Known causes of neuromuscular disease
• Inability to follow the procedures of the study

Eligibility criteria for patients

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Applied Sciences and Arts of Southern Switzerland

OTHER

Sponsor Role: collaborator

Clinical Trial Unit Ente Ospedaliero Cantonale

OTHER

Sponsor Role: collaborator

Alain Kaelin

OTHER

Sponsor Role: lead

Responsible Party

Alain Kaelin

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Neurocentro della Svizzera Italiana

Lugano, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Alain Kaelin, Prof.

Role: CONTACT

alain.kaelin@eoc.ch

+41 (0)91 811 62 57

Manuela Maffongelli

Role: CONTACT

manuela.maffongelli@supsi.ch

+41 (0)58 666 65 41

Facility Contacts

Alain Kaelin, Prof

Role: primary

alain.kaelin@eoc.ch

+41 (0)91 811 62 57

Claudio Gobbi, MD

Role: backup

claudio.gobbi@eoc.ch

+41 (0)91 811 69 21

Other Identifiers

SUPSI-2017-006

Identifier Type: -

Identifier Source: org_study_id