Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584084
Status:
RECRUITING
Last Update Posted:
None
First Post:
2018-01-23
Brief Title:
Technical and Clinical Validation of the WPM-SEMG Prototype
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Technical and Clinical Validation Study of a New Wireless Portable and Multi-Channel Surface EMG Device to Analyse Motor Unit Action Potentials
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None