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

Status Not yet recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03624296
Study type	Interventional
Source	Assistance Publique Hopitaux De Marseille
Contact	adil MAAROUF
Email	adil.maarouf@ap-hm.fr
Status	Not yet recruiting
Phase	N/A
Start date	October 2018
Completion date	March 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05177523` - Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis
Recruiting	`NCT04926818` - Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis	Phase 3
Terminated	`NCT04203498` - Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis	Phase 3
Active, not recruiting	`NCT04602390` - Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis	Phase 1
Completed	`NCT01804647` - Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease
Recruiting	`NCT04907305` - Next-Gen MS: Feed-forward PRO Data for MS Research
Active, not recruiting	`NCT03456206` - Chronic Inflammatory Disease, Lifestyle and Risk of Disease
Completed	`NCT04705610` - Social Cognition in Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography	N/A
Completed	`NCT01366027` - PRISM Registry: Pseudobulbar Affect Registry Series	N/A
Not yet recruiting	`NCT06053749` - An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden
Completed	`NCT03135249` - Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis	Phase 4
Recruiting	`NCT05633875` - Multimodal Imaging Signatures of the Biological Mechanisms Underlying Neurodegeneration in Multiple Sclerosis
Completed	`NCT02612935` - An Observational Pilot Study of Lumosity Computerized Cognitive Training in Subjects With Multiple Sclerosis	N/A
Completed	`NCT02739542` - Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)	Phase 4
Completed	`NCT03177655` - Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis	N/A
Active, not recruiting	`NCT04777539` - Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis
Recruiting	`NCT02352194` - Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis	N/A
Completed	`NCT02308579` - Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases	N/A
Withdrawn	`NCT01710228` - Alternative Treatment Paradigm for Natalizumab Trial	Phase 2
Completed	`NCT02019927` - Electric Stimulation of the Eye to Improve Vision After Trauma	N/A