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New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis (IRM-SLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04691011
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: Muscular MRI Other: Electrophysiological exam Other: Brain MRI Other: Spinal cord MRI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

3 groups :

  • muscle
  • brain
  • spinal cord
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
Actual Study Start Date : June 16, 2021
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Muscle Other: Muscular MRI
MRI (1.5T)

Other: Electrophysiological exam
MUNIX
Spinal cord Other: Muscular MRI
MRI (1.5T)

Other: Electrophysiological exam
MUNIX

Other: Spinal cord MRI
7T and 3T MRI
Brain Other: Muscular MRI
MRI (1.5T)

Other: Electrophysiological exam
MUNIX

Other: Brain MRI
MRI (7T)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Link between MRI and clinical scales [ Time Frame: Baseline and Month 6 ]
    ALSFRS score, MRC score, ECAS score

  2. Link between MRI and MUNIX [ Time Frame: Baseline and Month 6 ]
    For muscle, brain and spinal cord group

  3. Alterations of metabolic and funtional brain [ Time Frame: Baseline and Month 6 ]
    Multiparametric MRI (diffusion parameters, myelin parameters, quantification of fat-infiltration and oedema)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691011


Contacts
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Contact: Shahram Attarian 33491386579 shahram.attarian@ap-hm.fr
Contact: Jean Olivier Arnaud

Locations
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France
Shahram Attarian Recruiting
Marseille, France, 13005
Contact: Annie Verschueren       annie.verschueren@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Emilie Garrido Pradalié Direction Recherche Santé APHM
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT04691011    
Other Study ID Numbers: 2020-50
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases