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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis (MS)
• Intervention / Treatment: Device: MRI 7T; Other: TEST EDSS; Other: TEST MSFC

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: adil MAAROUF; Email: adil.maarouf@ap-hm.fr
• Study Contact Backup: Name: ALEXANDRA GIULIANI; Phone Number: +334 91 38 27 47; Email: drci@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille
    • Contact: alexandra GIULIANI; Phone Number: 04 91 38 27 47; Email: drci@ap-hm.fr
    • Principal Investigator: adil maarouf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visualization of cortical lesions	By IRM 7T	12 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure of physical disability	score EDSS	12 months
cognitive impairment index	score IAC	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: 2018-35; 2018-A00928-47 (Other Identifier: n°IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No