NCT07245589

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
44mo left

Started Dec 2025

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Dec 2025Nov 2029

First Submitted

Initial submission to the registry

October 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

October 2, 2025

Last Update Submit

November 17, 2025

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

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

    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

    Day 1

  • To estimate standard values of qMRI biomarkers

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

    Day 1

  • To estimate normative inter-examination reproducibility of qMRI biomarkers

    Inter-examination reproducibility (intra-individual repeatability)

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

Secondary Outcomes (2)

  • To evaluate external reproducibility using 10 healthy subjects

    Day 1

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

    Day 1

Study Arms (2)

MS Patients

EXPERIMENTAL
Other: 3T MRIOther: 7T MRIOther: Clinical examination of MS patientsOther: Neuropsychological testing of MS patients

Healthy Volunteers

SHAM COMPARATOR
Other: 3T MRIOther: 7T MRIOther: Quality of life questionnaires

Interventions

3T MRIOTHER

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

Healthy VolunteersMS Patients
7T MRIOTHER

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

Healthy VolunteersMS Patients
Clinical examination of MS patientsOTHER

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

MS Patients
Neuropsychological testing of MS patientsOTHER

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.

MS Patients
Quality of life questionnairesOTHER

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.

Healthy Volunteers

Eligibility Criteria

Age18 Years - 52 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For healthy volunteers :
  • Male or female aged 20 to 50
  • Subject without a history of traumatic brain injury
  • 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

You may not qualify if:

  • 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
  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Gui de Chauliac

Montpellier, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Jean PELLETIER

CONTACT

0491385941Jean.PELLETIER@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2025

First Posted

November 24, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

November 30, 2029

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)