Evaluation of the Clinical Contribution of Quantitative MRI in Neuro-i
Development of Quantitative MRI Neuroimaging Protocols at High Fields (3 Tesla) and Ultra-high Fields (7 Tesla) for Clinical Evaluation: Application to Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Clinical examination of MS patients
- Neuropsychological testing of MS patients
Placebo
- Quality of life questionnaires
Given to everyone in the trial
- 3T MRI
- 7T MRI
What it measured
Main measures
Assessing the feasibility of an accelerated 3T and 7T qMRI approach
Day 1
FeasibilityTo estimate standard values of qMRI biomarkers
Day 1
Blood or spinal fluid markersTo estimate normative inter-examination reproducibility of qMRI biomarkers
During the first visit at Day 1 and during the second visit at day 60
Blood or spinal fluid markers
Other measures (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
MRI lesions
Who could take part
MS (type not specified) · 18 to 52
Show the full 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)
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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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History
Started
Dec 2025
Main results due
Apr 2028
Finished
Nov 2029