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OpenTrials
Completed

NCT Number: NCT04691011

New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shahram Attarian

Marseille, 13005, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Muscular MRI

Other

MRI (1.5T)

Electrophysiological exam

Other

MUNIX

Brain MRI

Other

MRI (7T)

Spinal cord MRI

Other

7T and 3T MRI

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: IRM-SLA

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2020
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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