NCT04691011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

June 16, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2025

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

October 22, 2020

Last Update Submit

January 28, 2026

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Link between MRI and clinical scales

    Baseline and Month 6

  • Link between MRI and MUNIX

    Baseline and Month 6

  • Alterations of metabolic and funtional brain

    Baseline and Month 6

Study Arms (3)

Muscle

OTHER
Other: Muscular MRIOther: Electrophysiological exam

Spinal cord

OTHER
Other: Muscular MRIOther: Electrophysiological examOther: Spinal cord MRI

Brain

OTHER
Other: Muscular MRIOther: Electrophysiological examOther: Brain MRI

Interventions

Muscular MRIOTHER

MRI (1.5T)

BrainMuscleSpinal cord
Electrophysiological examOTHER

MUNIX

BrainMuscleSpinal cord
Brain MRIOTHER

MRI (7T)

Brain
Spinal cord MRIOTHER

7T and 3T MRI

Spinal cord

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahram Attarian

Marseille, 13005, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Emilie Garrido Pradalié

    Direction Recherche Santé APHM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 3 groups : * muscle * brain * spinal cord
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

December 31, 2020

Study Start

June 16, 2021

Primary Completion

June 4, 2025

Study Completion

June 4, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

FR(1)