EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the prognostic value of early focal lesions and early diffuse lesions on ambulatory disability progression within 5 years after clinical onset.

Detailed Description
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Prospective, multicentric study

Official Title
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EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: spinal cord MRI follow-up
* Other: clinical follow-up
* Other: brain MRI follow-up


Participation Criteria
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Eligibility Criteria
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Patients with multiple sclerosis: Inclusion Criteria: Relapsing Remitting Multiple Sclerosis patients (Mac Donald 2010 criteria) First clinical event < 1 year Brain MRI > 9 lesions or/and spinal cord attack with focal lesion on spinal cord MRI Score Expended Disability Status Scale < 3 Age between 18 and 40 years Exclusion Criteria: Multiple Sclerosis progressive Patients treated with immunosuppressive therapy Pregnancy Healthy volunteers: Inclusion Criteria: -Age between 18 and 40 years Exclusion Criteria: -Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with multiple sclerosis<br>80 patients / clinical Follow-up at M0, M6, M12, M18, M24, M30, M36, M42, M48, M54 and M60 / spinal cord MRI follow-up at M0, M12, M24, M36 and M60 / brain MRI follow-up at M0, M12, M24, M36 and M60 | Device: spinal cord MRI follow-up<br>* Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio<br>Other: clinical follow-up<br>* Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty<br>Other: brain MRI follow-up<br> <br> |
| Experimental: Healthy volunteers<br>20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24 | Device: spinal cord MRI follow-up<br>* Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive neurological disability | Measurement by Expended Disability Status Scale | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive ambulatory disability | Measurement by the 25-foot timed-Walked test and 6 minutes walking | 5 years | 
| Progressive disability in the upper limbs | Measurement by the nine-hole peg test | 5 years | 
| Progressive urinary disability | Measurement by the questionnaire Qualiveen | 5 years | 
| Progressive difficulty walking | Measurement by the Multiple Sclerosis Walking Scale 12 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, MRI, longitudinal study, disability, spinal cord