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Clinical Trials/NCT04691011
NCT04691011
Completed
Not Applicable

New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Assistance Publique Hopitaux De Marseille1 site in 1 country22 target enrollmentJune 16, 2021

Overview

Phase
Not Applicable
Intervention
Muscular MRI
Conditions
Amyotrophic Lateral Sclerosis
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
22
Locations
1
Primary Endpoint
Disease progression using MRI
Status
Completed
Last Updated
3 months ago

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.

Registry
clinicaltrials.gov
Start Date
June 16, 2021
End Date
June 4, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Muscle

Intervention: Electrophysiological exam

Spinal cord

Intervention: Muscular MRI

Spinal cord

Intervention: Electrophysiological exam

Spinal cord

Intervention: Spinal cord MRI

Brain

Intervention: Muscular MRI

Brain

Intervention: Electrophysiological exam

Brain

Intervention: Brain MRI

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)

Study Sites (1)

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