EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients
Not Applicable
- Conditions
- Multiple Sclerosis
- 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
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
- 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
CHU Rennes🇫🇷Rennes, France