Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis With Dementia Clinical Trial

— MIDALS  

Official title:

Contribution of Whole Body Muscle MRI for Early Diagnosis of Amyotrophic Lateral Sclerosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868994
• Other study ID #: RC31/20/0217
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Pascal CINTAS, MD PHD
• Phone: 05 61 77 94 40
• Email: cintas.p[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis With Dementia
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• Whole Body MRI and ENMG
Whole body muscle MRI lasting 30 to 45 min without injection of contrast medium an ENMG

Locations

Country	Name	City	State
France	Pascal CINTAS	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic certainty 1.ENMG according to El Escorial revised criteria using ENMG alone, MRI alone and ENMG+MRI to define denervation diffusion	number of patients classified as possible, probable or certain according to El Escorial criteria using ENMG alone, IMR alone and ENMR+MRI	1 month
Secondary	Define precise topographic and characteristic of muscle involvement in ALS by MRI	number of patients with concordance between ENMG and MRI for the detection of denervation	1 month