Clinical trial NCT02117375: EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients
Official title: EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
spinal cord
MRI
longitudinal study
disability
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Progressive neurological disability
timeFrame: 5 years
Secondary outcomes:
measure: Progressive ambulatory disability
timeFrame: 5 years
measure: Progressive disability in the upper limbs
timeFrame: 5 years
measure: Progressive urinary disability
timeFrame: 5 years
measure: Progressive difficulty walking
timeFrame: 5 years
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Gilles GE Edan
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Bruno BB Brochet
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Dijon
name: Thibault TM Moreau
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices civils Lyon
name: Sandra SV Vukusic
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HM
name: Jean JP Pelletier
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU NANCY
name: Marc MD Debouverie
role: PRINCIPAL_INVESTIGATOR
affiliation: Pitié Salpêtrière
name: Bruno BS Stankoff
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU REIMS
name: Ayman AT Tourbah
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Strasbourg
name: Jérôme JD De Seze
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Toulouse
name: David DB Brassat
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Montpellier
name: Pierre PL Labauge
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Thibaut TM Moreau
role: PRINCIPAL_INVESTIGATOR
References:
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.