EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients (EMISEP)
June 12, 2026 updated by: Rennes University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prospective, multicentric study
Study Type
Interventional
Enrollment (Actual)
115
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rennes, France
- CHU Rennes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with multiple sclerosis
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
|
Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio
Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty
|
|
Experimental: Healthy volunteers
20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24
|
Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progressive neurological disability
Time Frame: 5 years
|
Measurement by Expended Disability Status Scale
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progressive ambulatory disability
Time Frame: 5 years
|
Measurement by the 25-foot timed-Walked test and 6 minutes walking
|
5 years
|
|
Progressive disability in the upper limbs
Time Frame: 5 years
|
Measurement by the nine-hole peg test
|
5 years
|
|
Progressive urinary disability
Time Frame: 5 years
|
Measurement by the questionnaire Qualiveen
|
5 years
|
|
Progressive difficulty walking
Time Frame: 5 years
|
Measurement by the Multiple Sclerosis Walking Scale 12
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thibault TM Moreau, CHU Dijon
- Principal Investigator: Sandra SV Vukusic, Hospices civils Lyon
- Principal Investigator: Jean JP Pelletier, AP-HM
- Principal Investigator: Bruno BS Stankoff, Pitié Salpétrière
- Principal Investigator: Jérôme JD De Seze, CHU Strasbourg
- Principal Investigator: Pierre PL Labauge, University Hospital, Montpellier
- Principal Investigator: Thibaut TM Moreau, University Hospital, Clermont-Ferrand
- Principal Investigator: Gilles GE Edan, Rennes University Hospital
- Principal Investigator: Bruno BB Brochet, University Hospital, Bordeaux
- Principal Investigator: Marc MD Debouverie, Central Hospital, Nancy, France
- Principal Investigator: Ayman AT Tourbah, CHU de Reims
- Principal Investigator: David DB Brassat, University Hospital, Toulouse
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
January 24, 2023
Study Completion (Actual)
January 24, 2024
Study Registration Dates
First Submitted
April 10, 2014
First Submitted That Met QC Criteria
April 15, 2014
First Posted (Estimated)
April 17, 2014
Study Record Updates
Last Update Posted (Actual)
June 15, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-A00333-42
- PHRC/12-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.