New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

NCT ID: NCT04691011

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2025-06-04

Brief Summary

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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.

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

3 groups :

* muscle
* brain
* spinal cord
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Muscle

Group Type OTHER

Muscular MRI

Intervention Type OTHER

MRI (1.5T)

Electrophysiological exam

Intervention Type OTHER

MUNIX

Spinal cord

Group Type OTHER

Muscular MRI

Intervention Type OTHER

MRI (1.5T)

Electrophysiological exam

Intervention Type OTHER

MUNIX

Spinal cord MRI

Intervention Type OTHER

7T and 3T MRI

Brain

Group Type OTHER

Muscular MRI

Intervention Type OTHER

MRI (1.5T)

Electrophysiological exam

Intervention Type OTHER

MUNIX

Brain MRI

Intervention Type OTHER

MRI (7T)

Interventions

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Muscular MRI

MRI (1.5T)

Intervention Type OTHER

Electrophysiological exam

MUNIX

Intervention Type OTHER

Brain MRI

MRI (7T)

Intervention Type OTHER

Spinal cord MRI

7T and 3T MRI

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie Garrido Pradalié

Role: STUDY_DIRECTOR

Direction Recherche Santé APHM

Locations

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Shahram Attarian

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2020-50

Identifier Type: -

Identifier Source: org_study_id

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