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

CompletedNot a drug-phase studyMS (type not specified)NCT00861172

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • 3T MR scanner

What it measured

Main measures

  • 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

    MRI lesions

Other measures (2)

  • 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

    MRI lesions
  • Relation between plaques development and cerebral venous structures.

    each week for 2 months, at 6 month and at 12 month

Who could take part

MS (type not specified) · 18 to 50

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Feb 2009

    2. Main results due

      Jul 2012

    3. Finished

      Jul 2012

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