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

Rennes University Hospital115 enrolled

Overview

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.

Prospective, multicentric study

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

115

Conditions

Multiple Sclerosis

Interventions

spinal cord MRI follow-upDEVICE

Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio

clinical follow-upOTHER

Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty

brain MRI follow-upOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CHU Rennes

Rennes, France

Outcomes

Primary Outcomes

Progressive neurological disability

Measurement by Expended Disability Status Scale

Time frame: 5 years

Secondary Outcomes

Progressive ambulatory disability

Measurement by the 25-foot timed-Walked test and 6 minutes walking

Time frame: 5 years

Progressive disability in the upper limbs

Measurement by the nine-hole peg test

Time frame: 5 years

Progressive urinary disability

Measurement by the questionnaire Qualiveen

Time frame: 5 years

Progressive difficulty walking

Measurement by the Multiple Sclerosis Walking Scale 12

Time frame: 5 years

Data from ClinicalTrials.gov

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