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

Multiple Sclerosis (MS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03624296
• Other study ID #: 2018-35
• Secondary ID: 2018-A00928-47
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: March 2020

Study information

• Verified date: August 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: adil MAAROUF
• Email: adil.maarouf[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)

Intervention

Device:
• MRI 7T
MRI 7T

Other:
• TEST EDSS
EDSS - Expanded Disability Status Scale
• TEST MSFC
MSFC - Multiple Sclerosis Functional Composite

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visualization of cortical lesions	By IRM 7T	12 MONTHS
Secondary	measure of physical disability	score EDSS	12 months
Secondary	cognitive impairment index	score IAC	12 months