New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Study Overview
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Brief Summary
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Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Our project aims to find new biomarkers in MRI at three levels: cerebral, medullary and muscular. These markers could allow an earlier diagnosis of the disease by showing more specific lesions of ALS and to quantify these lesions to measure the progression of the disease. This study will use advanced Magnetic Resonance Imaging (MRI) techniques High field (3T) and very high field (7T) MRI. Results from neurological and electrophysiological tests will be compared to the MRI. Subjects will be recruited from ALS center of Marseille, France. MRI will be done on ALS patients at baseline, at 3 month and at 6 month intervals.

Official Title
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New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Other: Muscular MRI
* Other: Electrophysiological exam
* Other: Brain MRI
* Other: Spinal cord MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be adults with a diagnosis of ALS. Healthy controls will also be recruited and will be age- and gender-matched to patients. Patients able to undergo a brain MRI for approximately an hour. Exclusion Criteria: Subjects with other psychiatric or CNS or PNS diseases. Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body, or significant claustrophobia that could affect the ability to have an MRI scan.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 3 groups : muscle brain spinal cord
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Muscle<br> | Other: Muscular MRI<br>* MRI (1.5T)<br>Other: Electrophysiological exam<br>* MUNIX<br>|
| Other: Spinal cord<br> | Other: Muscular MRI<br>* MRI (1.5T)<br>Other: Electrophysiological exam<br>* MUNIX<br>Other: Spinal cord MRI<br>* 7T and 3T MRI<br>|
| Other: Brain<br> | Other: Muscular MRI<br>* MRI (1.5T)<br>Other: Electrophysiological exam<br>* MUNIX<br>Other: Brain MRI<br>* MRI (7T)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression using MRI | Muscular, brain and spinal cord MRI (brain sodium concentration, muscular volume of members, measure of transversal area for spinal cord) | Change from Baseline and at Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Link between MRI and clinical scales | ALSFRS score, MRC score, ECAS score | Baseline and Month 6 | 
| Link between MRI and MUNIX | For muscle, brain and spinal cord group | Baseline and Month 6 | 
| Alterations of metabolic and funtional brain | Multiparametric MRI (diffusion parameters, myelin parameters, quantification of fat-infiltration and oedema) | Baseline and Month 6 |