NCT07245589

Evaluation of the Clinical Contribution of Quantitative MRI in Neuro-imaging

Development of Quantitative MRI Neuroimaging Protocols at High Fields (3 Tesla) and Ultra-high Fields (7 Tesla) for Clinical Evaluation: Application to Multiple Sclerosis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years – 52 Years
• Healthy volunteers: Accepted

Summary

This study aims to develop the use of a quantitative MRI (qMRI) approach in neuroimaging for MS patients. To achieve this task the main goals of this study will be: * to standardize and optimize qMRI protocols (acquisition time, sensitivity) * to acquire ranges of normative values of qMRI parameters as a function of age and sex at high fields (3 Tesla) and ultra-high fields (UHF for ultra-high field, 7 Tesla) * To develop integrated tools for image processing and the generation of normative models of the healthy brain normative values * To assess the clinical feasibility and the multicenter validation of the multiparametric tools proposed in the case of application to MS.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	3T MRI	For this intervention, subjects will undergo a 3T MRI. The duration of an MRI session will not exceed 1h30
OTHER	7T MRI	For this intervention, healthy subjects and patients will undergo a 7T MRI. The duration of an MRI session will not exceed 1h30
OTHER	Clinical examination of MS patients	During this interevention, patients will be submitted to 2 tests the EDSS and the MSFC scores, assessing for physical and cognitive disabilities in patients.
OTHER	Neuropsychological testing of MS patients	This interventions consists in submitting MS patients to diverses neurpsychological tests assessing various parameters: CSCT (Computerized Speed Cognitive Test) for speed of information processing. PASAT (Paced Auditory Serial Addition Test) fo executive functions, working memory and attention CVLT (California Verbal Learning Test) for verbal episodic memory BVMTR (Brief Visual Memory Test) for visual episodic memory Fluences for mental flexibility, attention, lexical access "Test des commissions" for Ecological evaluation of executive functions Moreover, patients will fill out auto-questionnaires of quality of life including: a self-questionnaire of laterality (EDINBURGH), fatigue (MFIS), depression (BECK), anxiety (STAI1 and STAI2), quality of life (MUSIQOL), sleep quality (PITTSBURGH) and cognitive complaint (PDQ) will be collected for the volunteers.
OTHER	Quality of life questionnaires	This intervention consists in the completion diverse questionnaire assessing the quelity of life of the subject. These questionnaires include: a self-questionnaire of laterality (EDINBURGH), fatigue (MFIS), depression (BECK), anxiety (STAI1 and STAI2), quality of life (MUSIQOL), sleep quality (PITTSBURGH) and cognitive complaint (PDQ) will be collected for the volunteers. The completion of the self-questionnaires will take about 30 minutes.

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-04-30
• Completion: 2029-11-30
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: France