Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868994
Status:
RECRUITING
Last Update Posted:
2023-07-11
First Post:
2021-03-26
Brief Title:
Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Contribution of Whole Body Muscle MRI for Early Diagnosis of Amyotrophic Lateral Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIDALS
Brief Summary:
Nearly 60 of Amyotrophic Lateral Sclerosis ALS patients have a low level of diagnostic certainty possible probable at the time of diagnosis In the absence of biomarkers this diagnosis is based among other things on the demonstration of the diffusion of signs of denervation by electroneuromyography ENMG The objective of this study is to improve the earliness and the level of diagnostic certainty by better demonstrating the diffusion of the denervation process by whole body muscular MRI
Detailed Description:
The objective of this study is to show that the combination of ENMG and whole body muscle MRI WB-MRI can increase the diagnosis of definite ALS at the onset of the disease For 50 consecutive patients with suspected ALS the present study will prospectively perform needle electromyography EMG and muscle analyses on whole body MRI The diagnostic category will be determined by revised El Escorial criteria and Awaji criteria On whole body MRI acquisition for 83 muscles will be explored fatty infiltration and atrophy on fat images chronic denervation and muscle edema on water images acute denervation EMG studies will be performed in at least 10 muscles tongue biceps brachii first dorsalis interosseous T10 paraspinalis vastus lateralis and tibialis anterior Diagnostic classification according EMG and or MRI abnormalities in bulbar and the 3 spinal regions will be compared independently
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None