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

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: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: spinal cord MRI follow-up; Other: clinical follow-up; Other: brain MRI follow-up

Detailed Description

Prospective, multicentric study

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • Chu Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progressive neurological disability	Measurement by Expended Disability Status Scale	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Gros C, De Leener B, Badji A, Maranzano J, Eden D, Dupont SM, Talbott J, Zhuoquiong R, Liu Y, Granberg T, Ouellette R, Tachibana Y, Hori M, Kamiya K, Chougar L, Stawiarz L, Hillert J, Bannier E, Kerbrat A, Edan G, Labauge P, Callot V, Pelletier J, Audoin B, Rasoanandrianina H, Brisset JC, Valsasina P, Rocca MA, Filippi M, Bakshi R, Tauhid S, Prados F, Yiannakas M, Kearney H, Ciccarelli O, Smith S, Treaba CA, Mainero C, Lefeuvre J, Reich DS, Nair G, Auclair V, McLaren DG, Martin AR, Fehlings MG, Vahdat S, Khatibi A, Doyon J, Shepherd T, Charlson E, Narayanan S, Cohen-Adad J. Automatic segmentation of the spinal cord and intramedullary multiple sclerosis lesions with convolutional neural networks. Neuroimage. 2019 Jan 1;184:901-915. doi: 10.1016/j.neuroimage.2018.09.081. Epub 2018 Oct 6.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 17, 2014

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: MRI; multiple sclerosis; longitudinal study; disability; spinal cord
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 2013-A00333-42; PHRC/12-07