Multiple SclerosisNormaBRAINNCT07245589
Evaluation of the Clinical Contribution of Quantitative MRI in Neuro-imaging
A study testing 3T MRI, 7T MRI and Clinical examination of MS patients in people with Multiple Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- 3T MRI, 7T MRI and Clinical examination of MS patients
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- 3T MRI, 7T MRI, Clinical examination of MS patients, Neuropsychological testing of MS patients, Quality of life questionnaires
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T MRIOther
For this intervention, subjects will undergo a 3T MRI. The duration of an MRI session will not exceed 1h30
7T MRIOther
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 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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| MS Patients | Experimental | Not described Receives: Other: 3T MRI; Other: 7T MRI; Other: Clinical examination of MS patients; Other: Neuropsychological testing of MS patients |
| Healthy Volunteers | Sham comparator | Not described Receives: Other: 3T MRI; Other: 7T MRI; Other: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 1
To estimate normative inter-examination reproducibility of qMRI biomarkers
Inter-examination reproducibility (intra-individual repeatability)
Measured: 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
Comparing healthy volunteers quantitative parameters with standard values on the same age (average +/- 1.96 standard deviation)
Measured: Day 1
To Evaluate the clinical contribution of quantitative MRI on a population of 100 MS patients
Difference between MRI acquired data values and standard values (step 2), clinical contribution compared to the usual assessment (qualitative analysis).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245589
- Sponsor's protocol ID
- RCAPHM22_0366
- Other IDs
- ID-RCB 2025-A00346-43
- Acronym
- NormaBRAIN
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07245589
- Acronym / sponsor ID
- NormaBRAIN / RCAPHM22_0366
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS Patients | Experimental | Other: 3T MRI, Other: 7T MRI, Other: Clinical examination of MS patients, Other: Neuropsychological testing of MS patients |
| Healthy Volunteers | Sham comparator | Other: 3T MRI, Other: 7T MRI, Other: Quality of life questionnaires |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- For healthy volunteers :
- For MS patients
Key exclusion criteria (10 listed)
- For healthy subjects :
- For MS patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3T MRIFor this intervention, subjects will undergo a 3T MRI. The duration of an MRI session will not exceed 1h30 | Other | Healthy Volunteers, MS Patients |
| 7T MRIFor this intervention, healthy subjects and patients will undergo a 7T MRI. The duration of an MRI session will not exceed 1h30 | Other | Healthy Volunteers, MS Patients |
| Clinical examination of MS patientsDuring this interevention, patients will be submitted to 2 tests the EDSS and the MSFC scores, assessing for physical and cognitive disabilities in patients. | Other | MS Patients |
| Neuropsychological testing of MS patientsThis 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. | Other | MS Patients |
| Quality of life questionnairesThis 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. | Other | Healthy Volunteers |
Primary outcome
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
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
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)
2 secondary outcomes
To evaluate external reproducibility using 10 healthy subjects
Time frame: Day 1
To Evaluate the clinical contribution of quantitative MRI on a population of 100 MS patients
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3T MRI, 7T MRI and Clinical examination of MS patients in people with Multiple Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean PELLETIER (0491385941 ext. 33, Jean.PELLETIER@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the feasibility of an accelerated 3T and 7T qMRI approach (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.