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

NCT ID: NCT07245589

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2029-11-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MS Patients

Group Type: EXPERIMENTAL

3T MRI

Intervention Type: OTHER

For this intervention, subjects will undergo a 3T MRI. The duration of an MRI session will not exceed 1h30

7T MRI

Intervention Type: OTHER

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

Clinical examination of MS patients

Intervention Type: OTHER

During this interevention, patients will be submitted to 2 tests the EDSS and the MSFC scores, assessing for physical and cognitive disabilities in patients.

Neuropsychological testing of MS patients

Intervention Type: OTHER

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.

Healthy Volunteers

Group Type: SHAM_COMPARATOR

3T MRI

Intervention Type: OTHER

For this intervention, subjects will undergo a 3T MRI. The duration of an MRI session will not exceed 1h30

7T MRI

Intervention Type: OTHER

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

Quality of life questionnaires

Intervention Type: OTHER

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.

Interventions

3T MRI

For this intervention, subjects will undergo a 3T MRI. The duration of an MRI session will not exceed 1h30

Intervention Type: 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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Gui de Chauliac

Montpellier, , France

Countries

France

Central Contacts

Jean PELLETIER

Role: CONTACT

Jean.PELLETIER@ap-hm.fr

0491385941 ext. 33

Facility Contacts

Xavier AYRIGNAC

Role: primary

Other Identifiers

ID-RCB 2025-A00346-43

Identifier Type: OTHER

Identifier Source: secondary_id

RCAPHM22_0366

Identifier Type: -

Identifier Source: org_study_id