New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Muscular MRI; Other: Electrophysiological exam; Other: Spinal cord MRI; Other: Brain MRI

• Registration Number: NCT04691011
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2020-12-31
• Study Start: 2021-06-16
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal cord	Electrophysiological exam	-
Muscle	Electrophysiological exam	-
Muscle	Muscular MRI	-
Spinal cord	Muscular MRI	-
Brain	Muscular MRI	-
Brain	Electrophysiological exam	-
Spinal cord	Spinal cord MRI	-
Brain	Brain MRI	-

Primary Outcome Measures

Name	Time	Method
Disease progression using MRI	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

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

Trial Locations

Locations (1)

Shahram Attarian; 🇫🇷 Marseille, France