Evaluation of the Clinical Contribution of Quantitative MRI in Neuro-imaging (NormaBRAIN)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Other: 3T MRI; Other: Quality of life questionnaires; Other: Clinical examination of MS patients; Other: 7T MRI; Other: Neuropsychological testing of MS patients

Study type: Interventional

Funder types: Other

Identifiers

NCT07245589

ID-RCB 2025-A00346-43 (Other Identifier)

RCAPHM22_0366

Details and patient eligibility

About

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.

Enrollment: 272 estimated patients

Sex: All

Ages: 18 to 52 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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272 participants in 2 patient groups

MS Patients

Experimental group

Treatment:

Other: Neuropsychological testing of MS patients

Other: Clinical examination of MS patients

Other: 7T MRI

Other: 3T MRI

Healthy Volunteers

Sham Comparator group

Treatment:

Other: 7T MRI

Other: Quality of life questionnaires

Other: 3T MRI