Amyotrophic Lateral Sclerosis
Conditions
Brief summary
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.
Interventions
OTHERMuscular MRI
MRI (1.5T)
OTHERElectrophysiological exam
MUNIX
OTHERBrain MRI
MRI (7T)
OTHERSpinal cord MRI
7T and 3T MRI
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
3 groups : * muscle * brain * spinal cord
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression using MRI | Change from Baseline and at Month 6 | Muscular, brain and spinal cord MRI (brain sodium concentration, muscular volume of members, measure of transversal area for spinal cord) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Link between MRI and clinical scales | Baseline and Month 6 | ALSFRS score, MRC score, ECAS score |
| Link between MRI and MUNIX | Baseline and Month 6 | For muscle, brain and spinal cord group |
| Alterations of metabolic and funtional brain | Baseline and Month 6 | Multiparametric MRI (diffusion parameters, myelin parameters, quantification of fat-infiltration and oedema) |
Countries
France
Contacts
STUDY_DIRECTOREmilie Garrido Pradalié
Direction Recherche Santé APHM
Outcome results
None listed