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

Sponsor

Rennes University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02117375

Collaborator

(none)

115

Enrollment

Location

Arms

101.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Device: spinal cord MRI follow-up Other: clinical follow-up Other: brain MRI follow-up	N/A

Detailed Description

Prospective, multicentric study

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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	Device: spinal cord MRI follow-up Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio Other: clinical follow-up Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty Other: brain MRI follow-up
Experimental: Healthy volunteers 20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24	Device: spinal cord MRI follow-up Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio

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

Device: spinal cord MRI follow-up

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

Other: clinical follow-up

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

Other: brain MRI follow-up

Experimental: Healthy volunteers

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

Device: spinal cord MRI follow-up

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

Outcome Measures

Primary Outcome Measures

Progressive neurological disability [5 years]
Measurement by Expended Disability Status Scale

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Rennes	Rennes		France

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator: Gilles GE Edan, CHU Rennes
Principal Investigator: Bruno BB Brochet, CHU Bordeaux
Principal Investigator: Thibault TM Moreau, CHU Dijon
Principal Investigator: Sandra SV Vukusic, Hospices civils Lyon
Principal Investigator: Jean JP Pelletier, AP-HM
Principal Investigator: Marc MD Debouverie, CHU Nancy
Principal Investigator: Bruno BS Stankoff, Pitié Salpêtrière
Principal Investigator: Ayman AT Tourbah, CHU Reims
Principal Investigator: Jérôme JD De Seze, CHU Strasbourg
Principal Investigator: David DB Brassat, CHU Toulouse
Principal Investigator: Pierre PL Labauge, University Hospital, Montpellier
Principal Investigator: Thibaut TM Moreau, University Hospital, Clermont-Ferrand