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Multiple sclerosis (MS) is the most common acquired neurological disease leading to disability in young adults. MS often leads to the development of a physical and/or cognitive impairment that disables patients in their daily lives. Early use of disease modifying treatments for patients at risk of developing disability is therefore essential.
However, disability progression is very heterogeneous between patients and currently impossible to predict at the individual level. Thus, numerous studies, particularly epidemiological and imaging studies, have identified prognostic factors for the development of disability such as age, gender, number of relapses during the first years of the disease, existence of a residual disability after a first relapse, number of gadolinium-enhancing lesions on initial MRI, early brainstem and spinal cord lesions. However, these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients. In particular, some components of MS pathophysiology, more related to the progressive development of disability, such as axonal degeneration or the existence of chronic inflammation of the central nervous system (CNS) are usually not measured by these biomarkers.
In this research project, the investigators will test promising biomarkers, focused on these components of the disease, on a large cohort of patients in a multicenter setting, in order to evaluate their added value to predict disability progression, in comparison with more classical biomarkers such as clinical characteristics, and brain and spinal cord lesion load.
In particular, the investigators will test:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with MS | 250 patients with MRI, OCT and bio sample |
| |
| Healthy subjects | 50 healthy subjects with MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | Comparison between groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global disability progression | Global disability progression will be scored by the Expanded disability score system (EDSS). Disability progression will be defined as an increase in the EDSS of at least 1 point if the baseline EDSS was 5.5 or less, or 0.5 point if the Baseline EDSS was | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Composite disability progression score | A composite disability progression score will be defined as an increase in the EDSS score, or an increase in the time to perform the timed 25-foot walk ≥ 20%, or an increase in the time to complete the 9-hole peg test ≥ 20% at 2 years compared to baseline | 2 years |
| Change in the Symbol Digit Modalities Test score |
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For MS patients:
Inclusion Criteria:
Exclusion Criteria:
For healthy subjects:
Inclusion Criteria:
Exclusion Criteria:
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In order to ensure the inclusion of patients with different MS phenotypes representative of the general MS patients population in the VHD cohort, the investigators will aim to respect the inclusion percentages of at least 10% of patients with primary progressive MS and at least 15% of patients with secondary progressive MS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Kerbrat, Dr | Contact | +33 (0)2 99 28 43 21 | anne.kerbrat@chu-rennes.fr | |
| Eric Thouvenot, Pr. | Contact | eric.thouvenot@chu-nimes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lyon | Not yet recruiting | Lyon | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Serum
Change in the Symbol Digit Modalities Test (SDMT) score from baseline to 2-year |
| 2 years |
| Change in the American Spinal Cord Injury Association motor sub-score | Change in the American Spinal Cord Injury Association (ASIA) motor sub-score from baseline to 2-year | 2 years |
| Focal inflammatory activity | Focal inflammatory activity at 2 years will be defined by the occurrence of a clinical relapse and/or MRI activity (new T2 lesion) | 2 years |
| No evidence of disease activity 3 | No evidence of disease activity (NEDA) 3 at 2 years will be defined as no evidence of disability progression scored by the EDSS, relapse, MRI activity | 2 years |
| Between-subject, between-center and between-session coefficient of variation of measurements extracted quantitative MRI | Between-subject, between-center and between-session coefficient of variation (in percentage) of measurements extracted from baseline brain and spinal cord quantitative MRI (T1, Myelin water fraction, magnetization transfer ratio, parameters extracted from diffusion imaging) | At inclusion |
| Number of brain and spinal cord lesion detected using 3D MP2RAGE sequence and the classical OFSEP sequences at baseline and 2 year | At inclusion and 2 years |
| Number of new brain and spinal cord lesion detected at 2 years using 3DMP2RAGE sequence and the classical OFSEP sequences | 2 years |
| Number of detected brain and spinal cord lesions per patient and per expert with and without the automatic tool at baseline and 2 year | At baseline and 2 year |
| CHU de Nancy | Not yet recruiting | Nancy | France |
|
| CHU de Nîmes | Not yet recruiting | Nîmes | France |
|
| CHU de Rennes | Recruiting | Rennes | France |
|
| CHU de Strasbourg | Not yet recruiting | Strasbourg | France |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |