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

July 19, 2023 updated by: Assistance Publique Hopitaux De Marseille
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jean Olivier Arnaud

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Muscle
Other: Muscular MRI
MRI (1.5T)
Other: Electrophysiological exam
MUNIX
Other: Spinal cord
Other: Muscular MRI
MRI (1.5T)
Other: Electrophysiological exam
MUNIX
Other: Spinal cord MRI
7T and 3T MRI
Other: Brain
Other: Muscular MRI
MRI (1.5T)
Other: Electrophysiological exam
MUNIX
Other: Brain MRI
MRI (7T)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from Baseline and at Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Link between MRI and clinical scales
Time Frame: Baseline and Month 6
ALSFRS score, MRC score, ECAS score
Baseline and Month 6
Link between MRI and MUNIX
Time Frame: Baseline and Month 6
For muscle, brain and spinal cord group
Baseline and Month 6
Alterations of metabolic and funtional brain
Time Frame: Baseline and Month 6
Multiparametric MRI (diffusion parameters, myelin parameters, quantification of fat-infiltration and oedema)
Baseline and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Emilie Garrido Pradalié, Direction Recherche Santé APHM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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