Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Modification of MR parameters before and after the blood brain barrier disruption observed in newly enhancing lesion in MS.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Modification of MR parameters before and after the blood brain barrier disruption observed in newly enhancing lesion in MS.
时间窗: each week for 2 months, at 6 month and at 12 month
次要结局
- 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)