Clinical trial NCT00861172: Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy
Official title: Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lesions
Multiple Sclerosis
Keywords: Multiple sclerosis
Active plaque
Multimodal analysis
3T MRI
Weekly follow-up
Physiopathology
Physiopathology of active lesions formation in Multiple Sclerosis using multimodal MR sequences
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional MRI insofar as physiopathology is not well-known: the precise sequences of events leading to plaque formation and axonal injury are still not completely understood.

Some elements involved in plaque formation can be studied thanks to MR techniques (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral microcirculation's dysfunction).

This study aims at giving a better understanding of MS plaques' physiopathology, using data from modern MRI through a longitudinal followed up with weakly MR 3T examination.

Detailed description: The objective of this work are:

* study weakly development of the active MS plaque with multimodal MRI parameters using advanced MRI techniques: Veinography/3D FLAIR, Diffusion (CDA), Perfusion (CBV, CBF, MTT) MR Spectroscopy (NAA, myo-inositol, choline, lactate...) and enhanced 3DT1 sequences.
* define prognostic markers of MS aggressiveness ("black holes")
* Study development of MS plaque around venous structures.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 50 years.
* Health coverage.
* Any form of MS defined by Mc Donald's criteria (2005).
* Patients having shown an enhanced plaque on a less than six month MRI examination.

Exclusion Criteria:

* Patients with an immunomodulating therapy like natalizumab (Tysabri) and intravenous immunosuppressive therapies. Other therapies will not be excluded from this study. For patients treated by systemic corticotherapy, a one-month delay will be necessary before a MRI examination.
* Cerebral microangiopathy (diabetes, arterial hypertension, vascularitis...)
* Patient with classical MRI contraindication like pace-maker, cardiac valvulosis, claustrophobia, allergy to contrast agent ...
* Pregnancy or pregnancy desire.
* Patient with a low creatinine clearance \<60 ml/mn

Primary outcomes:
measure: Modification of MR parameters before and after the blood brain barrier disruption observed in newly enhancing lesion in MS.
timeFrame: each week for 2 months, at 6 month and at 12 month
Secondary outcomes:
measure: Predictive scorers of plaque transformation in "black-holes", which correspond with a pejorative evolution of accurate lesions, also defined by a focal destruction of cerebral tissue.
timeFrame: each week for 2 months, at 6 month and at 12 month
measure: Relation between plaques development and cerebral venous structures.
timeFrame: each week for 2 months, at 6 month and at 12 month
Other outcomes:
Locations:
city: BRON Cedex
country: France
facility: Services de Neurologie A et Service de Neuroradiologie, Pôle transversal d'imagerie, Hôpital Neurologique
Study officials:
affiliation: Hospices Civils de Lyon
name: Francois Cotton, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hannoun S, Roch JA, Durand-Dubief F, Vukusic S, Sappey-Marinier D, Guttmann CR, Cotton F. Weekly multimodal MRI follow-up of two multiple sclerosis active lesions presenting a transient decrease in ADC. Brain Behav. 2015 Feb;5(2):e00307. doi: 10.1002/brb3.307. Epub 2015 Jan 16.