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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Muscular MRI
Electrophysiological exam
Brain MRI
Spinal cord MRI
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shahram AttarianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Muscle

Spinal cord

Brain

Arm Description

Outcomes

Primary Outcome Measures

Disease progression using MRI
Muscular, brain and spinal cord MRI (brain sodium concentration, muscular volume of members, measure of transversal area for spinal cord)

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2020
Last Updated
July 19, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT04691011
Brief Title
New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
Acronym
IRM-SLA
Official Title
New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
3 groups : muscle brain spinal cord
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Muscle
Arm Type
Other
Arm Title
Spinal cord
Arm Type
Other
Arm Title
Brain
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Muscular MRI
Intervention Description
MRI (1.5T)
Intervention Type
Other
Intervention Name(s)
Electrophysiological exam
Intervention Description
MUNIX
Intervention Type
Other
Intervention Name(s)
Brain MRI
Intervention Description
MRI (7T)
Intervention Type
Other
Intervention Name(s)
Spinal cord MRI
Intervention Description
7T and 3T MRI
Primary Outcome Measure Information:
Title
Disease progression using MRI
Description
Muscular, brain and spinal cord MRI (brain sodium concentration, muscular volume of members, measure of transversal area for spinal cord)
Time Frame
Change from Baseline and at Month 6
Secondary Outcome Measure Information:
Title
Link between MRI and clinical scales
Description
ALSFRS score, MRC score, ECAS score
Time Frame
Baseline and Month 6
Title
Link between MRI and MUNIX
Description
For muscle, brain and spinal cord group
Time Frame
Baseline and Month 6
Title
Alterations of metabolic and funtional brain
Description
Multiparametric MRI (diffusion parameters, myelin parameters, quantification of fat-infiltration and oedema)
Time Frame
Baseline and Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahram Attarian
Phone
33491386579
Email
shahram.attarian@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Olivier Arnaud
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Garrido Pradalié
Organizational Affiliation
Direction Recherche Santé APHM
Official's Role
Study Director
Facility Information:
Facility Name
Shahram Attarian
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Verschueren
Email
annie.verschueren@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

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