EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients
NCT ID: NCT02117375
Last Updated: 2020-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
115 participants
INTERVENTIONAL
2014-01-31
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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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
spinal cord MRI follow-up
Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio
clinical follow-up
Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty
brain MRI follow-up
Healthy volunteers
20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24
spinal cord MRI follow-up
Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio
Interventions
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spinal cord MRI follow-up
Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio
clinical follow-up
Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty
brain MRI follow-up
Eligibility Criteria
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Inclusion 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
-Age between 18 and 40 years
Exclusion Criteria
* Patients treated with immunosuppressive therapy
* Pregnancy
Healthy volunteers:
-Pregnancy
18 Years
40 Years
ALL
Yes
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Gilles GE Edan
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
Bruno BB Brochet
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Thibault TM Moreau
Role: PRINCIPAL_INVESTIGATOR
CHU Dijon
Sandra SV Vukusic
Role: PRINCIPAL_INVESTIGATOR
Hospices civils Lyon
Jean JP Pelletier
Role: PRINCIPAL_INVESTIGATOR
AP-HM
Marc MD Debouverie
Role: PRINCIPAL_INVESTIGATOR
CHU NANCY
Bruno BS Stankoff
Role: PRINCIPAL_INVESTIGATOR
Pitié Salpêtrière
Ayman AT Tourbah
Role: PRINCIPAL_INVESTIGATOR
CHU REIMS
Jérôme JD De Seze
Role: PRINCIPAL_INVESTIGATOR
CHU Strasbourg
David DB Brassat
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Pierre PL Labauge
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Thibaut TM Moreau
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Rennes
Rennes, , France
Countries
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References
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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.
Other Identifiers
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PHRC/12-07
Identifier Type: -
Identifier Source: secondary_id
2013-A00333-42
Identifier Type: -
Identifier Source: org_study_id
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