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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 3T MRI
  For this intervention, subjects will undergo a 3T MRI. The duration of an MRI session will not exceed 1h30
• Другое 7T MRI
  For this intervention, healthy subjects and patients will undergo a 7T MRI. The duration of an MRI session will not exceed 1h30
• Другое 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.
• Другое 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 commissio
• Другое 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.

Первичные конечные точки

• Assessing the feasibility of an accelerated 3T and 7T qMRI approach [Срок оценки: Day 1]
• To estimate standard values of qMRI biomarkers [Срок оценки: Day 1]
• To estimate normative inter-examination reproducibility of qMRI biomarkers [Срок оценки: During the first visit at Day 1 and during the second visit at day 60]

Вторичные конечные точки (2)

• To evaluate external reproducibility using 10 healthy subjects [Срок оценки: Day 1]
• To Evaluate the clinical contribution of quantitative MRI on a population of 100 MS patients [Срок оценки: Day 1]

Критерии участия

Критерии включения

• For healthy volunteers :

• Male or female aged 20 to 50
• Subject with no history of previous or concomitant neurological and psychiatric diseases at the time of inclusion
• Subject without a history of traumatic brain injury
• Subject with no vascular history (arterial hypertension, stroke) or concomitant at the time of its inclusion
• Subject has no history of chronic drug and/or alcohol abuse
• Subject having received information regarding the study and having signed an informed consent
• Beneficiary or entitled person to a social security scheme
• For MS patients

• Male or female aged 18 to 52
• Patient diagnosed with MS according to the
• criteria of McDonald 2017
• Patient presenting a maximum EDSS of 6
• Patient with MS for less than 10 years of evolution
• Patient having received information regarding the study and having signed an informed consent
• Patient beneficiary or entitled to a plan of social security

Критерии исключения

• For healthy subjects :

• Subject presenting a contraindication to performing an MRI: pacemaker, presence of metal implants, claustrophobia.
• Subject unable to maintain a supine position for a prolonged period
• Subject in a period of exclusion from another research protocol at the time of signing consent/non-opposition form
• Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code (minor patient, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman)
• For MS patients

• Subject presenting a contraindication to performing an MRI: pacemaker, presence of metal implants, claustrophobia.
• Subject unable to maintain a supine position for a prolonged period
• Subject in a period of exclusion from another research protocol at the time of signing consent/non-opposition form
• Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code (minor patient, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Hôpital Gui de Chauliac — Montpellier

Идентификаторы

NCT: NCT07245589 · RCAPHM22_0366 · ID-RCB 2025-A00346-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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