Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis With Dementia
• Interventions: Diagnostic Test: Whole Body MRI and ENMG

• Registration Number: NCT04868994
• Lead Sponsor: University Hospital, Toulouse

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 Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-05-03
• Study Start: 2021-06-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ENMG and muscle analyses on whole body muscles MRI.	Whole Body MRI and ENMG	Diffusion of active and chronic muscle denervation will be assessed on ENMG and whole body muscle MRI. The diagnostic category will be determined by revised El Escorial criteria and Awaji criteria

Primary Outcome Measures

Name	Time	Method
Diagnostic certainty 1.ENMG according to El Escorial revised criteria using ENMG alone, MRI alone and ENMG+MRI to define denervation diffusion	1 month	number of patients classified as possible, probable or certain according to El Escorial criteria using ENMG alone, IMR alone and ENMR+MRI

Secondary Outcome Measures

Name	Time	Method
Define precise topographic and characteristic of muscle involvement in ALS by MRI	1 month	number of patients with concordance between ENMG and MRI for the detection of denervation

Trial Locations

Locations (1)

Pascal CINTAS; 🇫🇷 Toulouse, France