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

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Unknown status

CT.gov ID

NCT03624296

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

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

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

Primary Outcome Measures

visualization of cortical lesions [12 MONTHS]
By IRM 7T

Secondary Outcome Measures

measure of physical disability [12 months]
score EDSS
cognitive impairment index [12 months]
score IAC

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: jean-olivier ARNAUD, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT03624296

Other Study ID Numbers:

2018-35
2018-A00928-47

First Posted:

Aug 10, 2018

Last Update Posted:

Aug 10, 2018

Last Verified:

Aug 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Study Results

No Results Posted as of Aug 10, 2018