Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy

Not Applicable

Completed

• Conditions: Lesions; Multiple Sclerosis
• Interventions: Procedure: 3T MR scanner

• Registration Number: NCT00861172
• Lead Sponsor: Hospices Civils de Lyon

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	3T MR scanner	-

Primary Outcome Measures

Name	Time	Method
Modification of MR parameters before and after the blood brain barrier disruption observed in newly enhancing lesion in MS.	each week for 2 months, at 6 month and at 12 month

Secondary Outcome Measures

Name	Time	Method
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.	each week for 2 months, at 6 month and at 12 month
Relation between plaques development and cerebral venous structures.	each week for 2 months, at 6 month and at 12 month

Trial Locations

Locations (1)

Services de Neurologie A et Service de Neuroradiologie, Pôle transversal d'imagerie, Hôpital Neurologique; 🇫🇷 BRON Cedex, France