Amyotrophic Lateral SclerosisIRM-SLANCT04691011
New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
A study testing Muscular MRI, Electrophysiological exam and Brain MRI in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Muscular MRI, Electrophysiological exam and Brain MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2021to 4 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Muscular MRI, Electrophysiological exam, Brain MRI, Spinal cord MRI
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscular MRIOther
MRI (1.5T)
Electrophysiological examOther
MUNIX
Brain MRIOther
MRI (7T)
Spinal cord MRIOther
7T and 3T MRI
| Study group | Role | What they receive |
|---|---|---|
| Muscle | Other | Not described Receives: Other: Muscular MRI; Other: Electrophysiological exam |
| Spinal cord | Other | Not described Receives: Other: Muscular MRI; Other: Electrophysiological exam; Other: Spinal cord MRI |
| Brain | Other | Not described Receives: Other: Muscular MRI; Other: Electrophysiological exam; Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression using MRI
Muscular, brain and spinal cord MRI (brain sodium concentration, muscular volume of members, measure of transversal area for spinal cord)
Measured: Change from Baseline and at Month 6
Secondary outcomes (3)
Link between MRI and clinical scales
ALSFRS score, MRC score, ECAS score
Measured: Baseline and Month 6
Link between MRI and MUNIX
For muscle, brain and spinal cord group
Measured: Baseline and Month 6
Alterations of metabolic and funtional brain
Multiparametric MRI (diffusion parameters, myelin parameters, quantification of fat-infiltration and oedema)
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start16 Jun 2021
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 3 groups : * muscle * brain * spinal cord
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahram Attarian, MD, Principal investigator, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691011
- Sponsor's protocol ID
- 2020-50
- Acronym
- IRM-SLA
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2020
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT04691011
- Acronym / sponsor ID
- IRM-SLA / 2020-50
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups : * muscle * brain * spinal cord
| Arm | Type | Receives |
|---|---|---|
| Muscle | Other | Other: Muscular MRI, Other: Electrophysiological exam |
| Spinal cord | Other | Other: Muscular MRI, Other: Electrophysiological exam, Other: Spinal cord MRI |
| Brain | Other | Other: Muscular MRI, Other: Electrophysiological exam, Other: Brain MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscular MRIMRI (1.5T) | Other | Brain, Muscle, Spinal cord |
| Electrophysiological examMUNIX | Other | Brain, Muscle, Spinal cord |
| Brain MRIMRI (7T) | Other | Brain |
| Spinal cord MRI7T and 3T MRI | Other | Spinal cord |
Primary outcome
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)
3 secondary outcomes
Link between MRI and clinical scales
Time frame: Baseline and Month 6
Link between MRI and MUNIX
Time frame: Baseline and Month 6
Alterations of metabolic and funtional brain
Time frame: Baseline and Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahram Attarian, MD principal investigator
Assistance Publique - Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscular MRI, Electrophysiological exam and Brain MRI in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression using MRI (time frame: Change from Baseline and at Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.