Sclerosis, Multiple
Conditions
Brief summary
The development of in vivo biomarkers sensitive to myelin disruption represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.
Detailed description
The development of in vivo biomarkers sensitive to myelin disruption (demyelination and remyelination) represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.
Interventions
DEVICEinhomogeneous Magnetisation Transfer (ihMT) sequence
robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T
DEVICEinhomogeneous Magnetisation Transfer (ihMT) sequence at 3T
robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* For Patients and Controls : * Adult patient, male and female, age 18 to 45 * Patient affiliated with health insurance coverage, * Patient who signed a free and informed consent after receiving detailed, understandable and honest information, * For patients only : * Patient with relapsing-remitting multiple sclerosis according to the McDonald 2010 criteria or progressive * Patients treated or not treated with first-line disease modifying therapy * Detection of at least one post-Gadolinium injection active lesion identified on the initial brain MRI (T0) or a chronic active lesion (PRL: Paramagnetic rim lesions)
Exclusion criteria
* For patients only : • Patients with a progressive form of MS other than the early relapsing-remitting form (primary progressive or secondary progressive) * For Patients and Controls : * Patients with the usual contraindications for MRI (pacemaker, agitation, metal shards, claustrophobia) * Patients at risk of non-compliance to the exam: basic problems with understanding, confusion, involuntary movements, poor tolerance of prolonged supine position * Patients who are unable to give their consent: problems with understanding, lack of vigilance, confusion * Woman who is pregnant and breastfeeding * Patients with a history of neurological or psychiatric condition * Patients under guardianship or trusteeship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ihMTR ratio at 1.5TMRI | 1 year | ihMT 3D technique at 1.5TMRI on active lesions with baseline measurements |
| Magnetic transfert (MT) at 1.5TMRI | 1 year | relative signal variations of the conventional magnetization transfer (MT) |
| Myelin water fraction at 1.5TMRI | 1 year | myelin water fraction (MWF), an MRI biomarker of myelin, in new MS lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ihMTR ratio at 3TMRI | 1 year | Relative variations in ihMTR ratio measured at 3T will be compared to those measured at 1.5T at the same points in time to opmtimize 3D ihMT technique at 3TMRI |
| Evaluate the predictive value of ihMT | 1 year | Evaluate the predictive value of the measured dynamics with respect to the final progression of the lesions |
Countries
France
Contacts
CONTACTJEAN PELLETIER, MD
STUDY_DIRECTOREMILIE GARRIDO PRADALIE
APHM
Outcome results
None listed