New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Disease progression using MRI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Muscle
Intervention: Muscular MRI (Other)
Muscle
Intervention: Electrophysiological exam (Other)
Spinal cord
Intervention: Muscular MRI (Other)
Spinal cord
Intervention: Electrophysiological exam (Other)
Spinal cord
Intervention: Spinal cord MRI (Other)
Brain
Intervention: Muscular MRI (Other)
Brain
Intervention: Electrophysiological exam (Other)
Brain
Intervention: Brain MRI (Other)
Outcomes
Primary Outcomes
Disease progression using MRI
Time Frame: 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 Outcomes
- Alterations of metabolic and funtional brain(Baseline and Month 6)
- Link between MRI and clinical scales(Baseline and Month 6)
- Link between MRI and MUNIX(Baseline and Month 6)