Pascal CINTAS
Toulouse, 31000, France
Location status: Recruiting
NCT Number: NCT04868994
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.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Toulouse, 31000, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Whole body muscle MRI lasting 30 to 45 min without injection of contrast medium an ENMG
Time frame: 1 month
number of patients classified as possible, probable or certain according to El Escorial criteria using ENMG alone, IMR alone and ENMR+MRI
Time frame: 1 month
number of patients with concordance between ENMG and MRI for the detection of denervation
Contact information is provided by the study sponsor or research team.
Anne Cecile Coville
CONTACT
Pascal CINTAS, MD PHD
CONTACT
University Hospital, Toulouse
Other
Contribution of Whole Body Muscle MRI for Early Diagnosis of Amyotrophic Lateral Sclerosis.
Acronym: MIDALS
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