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

NCT03624296 | Unknown

• 2 other identifiers: 2018-352018-A00928-47
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• visualization of cortical lesions

  By IRM 7T

  12 MONTHS

Secondary Outcomes (2)

• measure of physical disability

  12 months

• cognitive impairment index

  12 months

Study Arms (1)

patient with multiple sclerosis (MS)

EXPERIMENTAL

Device: MRI 7T; Other: TEST EDSS; Other: TEST MSFC

Interventions

MRI 7T DEVICE

MRI 7T

patient with multiple sclerosis (MS)

TEST EDSS OTHER

EDSS - Expanded Disability Status Scale

patient with multiple sclerosis (MS)

TEST MSFC OTHER

MSFC - Multiple Sclerosis Functional Composite

patient with multiple sclerosis (MS)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• jean-olivier ARNAUD

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

adil MAAROUF

CONTACT

adil.maarouf@ap-hm.fr

ALEXANDRA GIULIANI

CONTACT

+334 91 38 27 47; drci@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 10, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

FR (1)