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

NCT ID: NCT03624296

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2020-03-31

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.

Conditions

Multiple Sclerosis (MS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patient with multiple sclerosis (MS)

Group Type: EXPERIMENTAL

MRI 7T

Intervention Type: DEVICE

MRI 7T

TEST EDSS

Intervention Type: OTHER

EDSS - Expanded Disability Status Scale

TEST MSFC

Intervention Type: OTHER

MSFC - Multiple Sclerosis Functional Composite

Interventions

MRI 7T

MRI 7T

Intervention Type: DEVICE

TEST EDSS

EDSS - Expanded Disability Status Scale

Intervention Type: OTHER

TEST MSFC

MSFC - Multiple Sclerosis Functional Composite

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jean-olivier ARNAUD

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Central Contacts

adil MAAROUF

Role: CONTACT

adil.maarouf@ap-hm.fr

ALEXANDRA GIULIANI

Role: CONTACT

drci@ap-hm.fr

+334 91 38 27 47

Facility Contacts

alexandra GIULIANI

Role: primary

drci@ap-hm.fr

04 91 38 27 47

Other Identifiers

2018-A00928-47

Identifier Type: OTHER

Identifier Source: secondary_id

2018-35

Identifier Type: -

Identifier Source: org_study_id