Multiple SclerosisSEP-MRINCT03356366
MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis
A study testing MRI 3T, MRI 1,5T and MRI 7T in people with Multiple Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Multiple sclerosis (MS) is the first non-traumatic cause of disability in young people, responsible for physical but also cognitive deficits. MS is an inflammatory demyelinating and degenerative disease of the central nervous system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MRI 3T, MRI 1,5T and MRI 7T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2017to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient,
- Patient affiliated to a health insurance plan
- Patient having signed free and informed consent after receiving detailed, understandable and honest information,
- Patient with multiple sclerosis according to the criteria of Polman 2010
Who cannot join
- Patients with the usual contraindications to MRI (pace-maker, agitation, metal splinters, claustrophobia etc.)
- Patients at risk of non-compliance on examination: impaired understanding, confusion, involuntary movements, poor tolerance of prolonged supine
- Patients with known allergy to gadolinium
- Patients with renal insufficiency
- Patients unable to give their consent: disorders of the comprehension, disturbances of vigilance, confusion ...
- Pregnant and breastfeeding woman
- Patients with a history of neurological or psychiatric pathology
- Patients under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Imaging Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis
Multiple sclerosis (MS) is the first non-traumatic cause of disability in young people, responsible for physical but also cognitive deficits. MS is an inflammatory demyelinating and degenerative disease of the central nervous system. Recently, MRI technics have demonstrated their sensibility to the different processes involved in MS. Particularly, MRI has evidenced that the pathological process of MS is not restricted to the macroscopic lesions of the white matter but also involves the normal appearing white and grey matter. In the normal appearing brain tissue, demyelination, neuronal suffering and neuronal loss have been evidenced. Moreover, MRI has demonstrated the existence of brain functional reorganization processes that may limit the clinical expression of pathological injuries. Despite these important findings, the pathological underpinnings of irreversible disability are largely unknown. The present project aims to depict the main determinants of physical but also cognitive disability in patients with MS. To do this, a longitudinal study including 70 patients with MS using different MRI markers known to be sensitive to the different pathological aspects of MS will be performed. The relationships between these markers and the progression of disability will be assessed. Identification of the main pathological underpinnings of irreversible disability of MS will provide the most relevant therapeutic targets.
- Conditions
- Multiple Sclerosis
- Being tested
- MRI 3T, MRI 1,5T, MRI 7T
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI 3TOther
Magnetic Resonance Imaging 3 Tesla
MRI 1,5TOther
Magnetic Resonance Imaging 1,5 Tesla
MRI 7TOther
Magnetic Resonance Imaging 7 Tesla
| Study group | Role | What they receive |
|---|---|---|
| Principal study | Experimental | Patients pathological process will be assessed using MRI 3T Receives: Other: MRI 3T |
| Ancillary study 1 | Experimental | Patients pathological process will be assessed using MRI 1,5T Receives: Other: MRI 1,5T |
| Ancillary study 2 | Experimental | Patients pathological process will be assessed using MRI 7T Receives: Other: MRI 7T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the Expanded Disability Status Scale (EDSS) value (score from 0 to 20) constituing the actual international reference scale to measure the level of disability caused by parkinson disease
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start2 Oct 2017
- Primary completion16 Jan 2023
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356366
- Sponsor's protocol ID
- 2016-52
- Other IDs
- 2017-A00136-47
- Acronym
- SEP-MRI
- Status last verified
- Aug 2024
- First submitted
- 6 Nov 2017
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03356366
- Acronym / sponsor ID
- SEP-MRI / 2016-52
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Nov 2017 (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.
Multiple sclerosis (MS) is the first non-traumatic cause of disability in young people, responsible for physical but also cognitive deficits. MS is an inflammatory demyelinating and degenerative disease of the central nervous system. Recently, MRI technics have demonstrated their sensibility to the different processes involved in MS. Particularly, MRI has evidenced that the pathological process of MS is not restricted to the macroscopic lesions of the white matter but also involves the normal appearing white and grey matter. In the normal appearing brain tissue, demyelination, neuronal suffering and neuronal loss have been evidenced. Moreover, MRI has demonstrated the existence of brain functional reorganization processes that may limit the clinical expression of pathological injuries. Despite these important findings, the pathological underpinnings of irreversible disability are largely unknown. The present project aims to depict the main determinants of physical but also cognitive disability in patients with MS. To do this, a longitudinal study including 70 patients with MS using different MRI markers known to be sensitive to the different pathological aspects of MS will be performed. The relationships between these markers and the progression of disability will be assessed. Identification of the main pathological underpinnings of irreversible disability of MS will provide the most relevant therapeutic targets.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Principal study | Experimental | Other: MRI 3TPatients pathological process will be assessed using MRI 3T |
| Ancillary study 1 | Experimental | Other: MRI 1,5TPatients pathological process will be assessed using MRI 1,5T |
| Ancillary study 2 | Experimental | Other: MRI 7TPatients pathological process will be assessed using MRI 7T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient,
- Patient affiliated to a health insurance plan
- Patient having signed free and informed consent after receiving detailed, understandable and honest information,
- Patient with multiple sclerosis according to the criteria of Polman 2010
Key exclusion criteria (8 listed)
- Patients with the usual contraindications to MRI (pace-maker, agitation, metal splinters, claustrophobia etc.)
- Patients at risk of non-compliance on examination: impaired understanding, confusion, involuntary movements, poor tolerance of prolonged supine
- Patients with known allergy to gadolinium
- Patients with renal insufficiency
- Patients unable to give their consent: disorders of the comprehension, disturbances of vigilance, confusion ...
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 |
|---|---|---|
| MRI 3TMagnetic Resonance Imaging 3 Tesla | Other | Principal study |
| MRI 1,5TMagnetic Resonance Imaging 1,5 Tesla | Other | Ancillary study 1 |
| MRI 7TMagnetic Resonance Imaging 7 Tesla | Other | Ancillary study 2 |
Primary outcome
Measurement of the Expanded Disability Status Scale (EDSS) value (score from 0 to 20) constituing the actual international reference scale to measure the level of disability caused by parkinson disease
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Olivier ARNAUD study director
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 MRI 3T, MRI 1,5T and MRI 7T in people with Multiple 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Measurement of the Expanded Disability Status Scale (EDSS) value (score from 0 to 20) constituing the actual international reference scale to measure the level of disability caused by parkinson disease (time frame: 5 years). 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 6 Aug 2024.