New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

— IRM-SLA  

Official title:

New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691011
• Other study ID #: 2020-50
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Shahram Attarian
• Phone: 33491386579
• Email: shahram.attarian[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• Muscular MRI
MRI (1.5T)
• Electrophysiological exam
MUNIX
• Brain MRI
MRI (7T)
• Spinal cord MRI
7T and 3T MRI

Locations

Country	Name	City	State
France	Shahram Attarian	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease progression using MRI	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	Link between MRI and clinical scales	ALSFRS score, MRC score, ECAS score	Baseline and Month 6
Secondary	Link between MRI and MUNIX	For muscle, brain and spinal cord group	Baseline and Month 6
Secondary	Alterations of metabolic and funtional brain	Multiparametric MRI (diffusion parameters, myelin parameters, quantification of fat-infiltration and oedema)	Baseline and Month 6