Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole Body MRI and ENMG.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis With Dementia. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Contribution of Whole Body Muscle MRI for Early Diagnosis of Amyotrophic Lateral Sclerosis.
Overview
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.
Interventions
- Diagnostic test Whole Body MRI and ENMG
Whole body muscle MRI lasting 30 to 45 min without injection of contrast medium an ENMG
Primary outcome measures
- Diagnostic certainty 1.ENMG according to El Escorial revised criteria using ENMG alone, MRI alone and ENMG+MRI to define denervation diffusion [Time frame: 1 month]
Secondary outcome measures (1)
- Define precise topographic and characteristic of muscle involvement in ALS by MRI [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- Consent form signed by the patient
- Patients suspected ALS defined according Awaji Shima criteria (possible, probable, defined)
- Clinical assessment of upper motor neuron involvement
- Electrophysiologic assessment of lower motor neuron involvement
Exclusion criteria
- inability to give informed consent
- a contraindication to MRI
- respiratory failure impairing ability to lie flat in the scanner.
- Patient placed under judicial protection or under another protective regime,
- Females who are pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Pascal CINTAS — Toulouse
Identifiers
NCT: NCT04868994 · RC31/20/0217