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

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Device: spinal cord MRI follow-up; Other: clinical follow-up; Other: brain MRI follow-up

• Registration Number: NCT02117375
• Lead Sponsor: Rennes University Hospital

Brief Summary

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

Prospective, multicentric study

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11
• Primary Completion: 2022-04
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with multiple sclerosis	spinal cord MRI follow-up	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
Patients with multiple sclerosis	brain MRI follow-up	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
Patients with multiple sclerosis	clinical follow-up	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
Healthy volunteers	spinal cord MRI follow-up	20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24

Primary Outcome Measures

Name	Time	Method
Progressive neurological disability	5 years	Measurement by Expended Disability Status Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France