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NCT Number: NCT07245589

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–52 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Gui de Chauliac

Montpellier, France

Location contact

Xavier AYRIGNAC

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

3T MRI

Other

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

7T MRI

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

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

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.

Quality of life questionnaires

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.

Primary outcomes

  1. Assessing the feasibility of an accelerated 3T and 7T qMRI approach

    Time frame: Day 1

    Sensitivity per unit of acquisition time (signal-to-noise ratio, SNR), short-term inter-examination reproducibility (intra-individual repeatability), as well as the minimum acquisition duration

  2. To estimate standard values of qMRI biomarkers

    Time frame: Day 1

    qMRI metrics calculated over region of interests defined in white and gray matter, mean and standard deviation of qMRI parameters

  3. To estimate normative inter-examination reproducibility of qMRI biomarkers

    Time frame: During the first visit at Day 1 and during the second visit at day 60

    Inter-examination reproducibility (intra-individual repeatability)

Secondary outcomes

  1. To evaluate external reproducibility using 10 healthy subjects

    Time frame: Day 1

    Comparing healthy volunteers quantitative parameters with standard values on the same age (average +/- 1.96 standard deviation)

  2. To Evaluate the clinical contribution of quantitative MRI on a population of 100 MS patients

    Time frame: Day 1

    Difference between MRI acquired data values and standard values (step 2), clinical contribution compared to the usual assessment (qualitative analysis).

Study contacts

Contact information is provided by the study sponsor or research team.

Jean PELLETIER

CONTACT

[email protected]

0491385941 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: NormaBRAIN

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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