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Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study

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ClinicalTrials.gov Identifier: NCT03624296
Recruitment Status : Unknown
Verified August 2018 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Brief Summary:

The main aim of the present study is to assess the prevalence, the topography and the clinical counterpart of cortical lesions in patient included early after the first clinical episode of multiple sclerosis. A second aim is to assess the direct contribution of cortical lesions - independent of WM injury - on the diffuse grey matter damage.

Thirty MS patients will be included in the six months after the first clinical episode of multiple sclerosis for a monocentric transversal MRI study at 7T to assess cortical MS injury. Clinical (EDSS) and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. MRI protocol is designed to increase the detection rate of CL using multiple contrasts at high isotropic resolution (600µm3) on a whole brain exploration. Thus, MRI acquisition will include MP2RAGE, T2*, FLAIR and DIR as previously published but also recent MRI technique like FLAWS, focusing on the grey matter by attenuating the white matter and CSF signal. Finally, QSM sequences will be performed. QSM measures tissue magnetic susceptibility mostly influenced by iron, myelin and calcium content in the brain. Due to physical properties of the technique (bipolarity), we suppose that high resolution QSM will be more sensitive that previous used sequences to depict cortical lesions. Using this multi-contrast approach with relevant MRI sequence and with a high resolution whole brain exploration might improve the detection of CL in early MS.

Furthermore, MRI protocol allow us to estimate neuronal loss (T1 relaxation time), myelin and iron content (QSM and T2* relaxation time) within and outside cortical lesions in GM.

The present study is an opportunity to assess cortical pathology in MS from the onset of the disease, allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary requirement to longitudinal studies to precisely depict the kinetic of cortical lesion accumulation and the links with disease aggravation.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis (MS) Device: MRI 7T Other: TEST EDSS Other: TEST MSFC Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: patient with multiple sclerosis (MS) Device: MRI 7T
MRI 7T

Other: TEST EDSS
EDSS - Expanded Disability Status Scale

Other: TEST MSFC
MSFC - Multiple Sclerosis Functional Composite


Outcome Measures
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Primary Outcome Measures :
  1. visualization of cortical lesions [ Time Frame: 12 MONTHS ]
    By IRM 7T


Secondary Outcome Measures :
  1. measure of physical disability [ Time Frame: 12 months ]
    score EDSS

  2. cognitive impairment index [ Time Frame: 12 months ]
    score IAC


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with relapsing-remitting MS (McDonald's criteria 2010) early (duration evolution <2 years),
  • Age between 18 and 45 years,
  • No history of neurological symptoms suggestive of demyelinating pathology,
  • No corticosteroids in the month preceding the completion of the MRI,
  • Realization of the MRI in the first 6 months following the inaugural clinical episod

Exclusion Criteria:

  • Argument for a differential diagnosis (systemic lupus erythematosus, antiphospholipid syndrome, Behçet's disease, sarcoidosis, Lyme disease, cerebral arteritis, lymphoma CNS, etc.),
  • History of neurological or psychiatric illness,
  • History of taking immunosuppressive drugs,
  • Claustrophobia
  • Pregnancy,
  • Patient unable or unwilling to give consent, patient under guardianship,
  • Patient not affiliated to a social security regime
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624296


Contacts
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Contact: adil MAAROUF adil.maarouf@ap-hm.fr
Contact: ALEXANDRA GIULIANI +334 91 38 27 47 drci@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Contact: alexandra GIULIANI    04 91 38 27 47    drci@ap-hm.fr   
Principal Investigator: adil maarouf         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: jean-olivier ARNAUD Assistance Publique Hopitaux De Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03624296    
Other Study ID Numbers: 2018-35
2018-A00928-47 ( Other Identifier: n°IDRCB )
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases