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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03624296
Enrollment
30
Registered
2018-08-10
Start date
2018-10-31
Completion date
2020-03-31
Last updated
2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis (MS)

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.

Interventions

DEVICEMRI 7T

MRI 7T

OTHERTEST EDSS

EDSS - Expanded Disability Status Scale

OTHERTEST MSFC

MSFC - Multiple Sclerosis Functional Composite

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visualization of cortical lesions12 MONTHSBy IRM 7T

Secondary

MeasureTime frameDescription
measure of physical disability12 monthsscore EDSS
cognitive impairment index12 monthsscore IAC

Countries

France

Contacts

Primary Contactadil MAAROUF
adil.maarouf@ap-hm.fr
Backup ContactALEXANDRA GIULIANI
drci@ap-hm.fr+334 91 38 27 47

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026