EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients (EMISEP)
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
spinal cord MRI follow-up
clinical follow-up
brain MRI follow-up
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis focused on measuring multiple sclerosis, spinal cord, MRI, longitudinal study, disability
Eligibility 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
Sites / Locations
- CHU Rennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients with multiple sclerosis
Healthy volunteers
Arm 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
20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24
Outcomes
Primary Outcome Measures
Progressive neurological disability
Measurement by Expended Disability Status Scale
Secondary Outcome Measures
Progressive ambulatory disability
Measurement by the 25-foot timed-Walked test and 6 minutes walking
Progressive disability in the upper limbs
Measurement by the nine-hole peg test
Progressive urinary disability
Measurement by the questionnaire Qualiveen
Progressive difficulty walking
Measurement by the Multiple Sclerosis Walking Scale 12
Full Information
NCT ID
NCT02117375
First Posted
April 10, 2014
Last Updated
June 8, 2020
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02117375
Brief Title
EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients
Acronym
EMISEP
Official Title
EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
Detailed Description
Prospective, multicentric study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, spinal cord, MRI, longitudinal study, disability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with multiple sclerosis
Arm Type
Experimental
Arm 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
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24
Intervention Type
Device
Intervention Name(s)
spinal cord MRI follow-up
Intervention Description
Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio
Intervention Type
Other
Intervention Name(s)
clinical follow-up
Intervention Description
Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty
Intervention Type
Other
Intervention Name(s)
brain MRI follow-up
Primary Outcome Measure Information:
Title
Progressive neurological disability
Description
Measurement by Expended Disability Status Scale
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progressive ambulatory disability
Description
Measurement by the 25-foot timed-Walked test and 6 minutes walking
Time Frame
5 years
Title
Progressive disability in the upper limbs
Description
Measurement by the nine-hole peg test
Time Frame
5 years
Title
Progressive urinary disability
Description
Measurement by the questionnaire Qualiveen
Time Frame
5 years
Title
Progressive difficulty walking
Description
Measurement by the Multiple Sclerosis Walking Scale 12
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles GE Edan
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno BB Brochet
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thibault TM Moreau
Organizational Affiliation
CHU Dijon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra SV Vukusic
Organizational Affiliation
Hospices civils Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean JP Pelletier
Organizational Affiliation
AP-HM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc MD Debouverie
Organizational Affiliation
CHU Nancy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno BS Stankoff
Organizational Affiliation
Pitié Salpêtrière
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayman AT Tourbah
Organizational Affiliation
CHU Reims
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jérôme JD De Seze
Organizational Affiliation
CHU Strasbourg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David DB Brassat
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre PL Labauge
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thibaut TM Moreau
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30300751
Citation
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.
Results Reference
derived
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EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients
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