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

Rennes University Hospital

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Other: clinical follow-up; Device: spinal cord MRI follow-up; Other: brain MRI follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT02117375

PHRC/12-07

2013-A00333-42

Details and patient eligibility

About

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.

Full description

Prospective, multicentric study

Enrollment: 115 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

115 participants in 2 patient groups

Patients with multiple sclerosis

Experimental group

Description:

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

Treatment:

Device: spinal cord MRI follow-up

Other: clinical follow-up

Other: brain MRI follow-up

Healthy volunteers

Experimental group

Description:

20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24

Treatment:

Device: spinal cord MRI follow-up