Study by Magnetic Resonance Imaging of the Modifications of the Vasoreactivity and Cerebral Connectivity in the Progressive Forms of Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Cerebral vasoreactivity measured by diffusion imaging MRI (quantitative variable) :parameter which allow us to estimate the organization of the white matter tracts
研究概览
简要总结
The goal of this study is to show pattern differences of vasoreactivity and connectivity between Progressive Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, by the use of methods of advanced brain MRIs and the Diffusion Tensor Imaging , and correlate these differences with Clinical disability and cognitive disorder results.
详细描述
The goal of this study is to show pattern differences of vasoreactivity and connectivity between Progressive Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, by the use of methods of advanced brain MRIs, and correlate these differences with Clinical disability and cognitive disorder results. The modification of the Diffusion Tensor Imaging are well known in these two groups, as well as their link with the occurrence of movement and cognitive disorder. The study of the vasoreactivity during MRI aims to confront our results to the available data sources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Both patients and healthy volunteers :
- •Age limits ≥ 30 et ≤ 50 years
- •Subject able to understand the nature, the aim and the methodology of the study.
- •Collection of the informed consent
- •Affiliation or recipient with the mode of social security.
- •For the patients :
- •Suffering from progressive multiple sclerosis (primary progressive forms or secondary progressive forms) OR
- •Suffering from relapsing-remitting multiple sclerosis
排除标准
- •For Both patients and healthy volunteers :
- •Systemic pathology with neurological manifestations
- •Antecedent of psychiatric disorders including psychosis (Except anxious depressive disorder)
- •Subject presenting contraindications in MRI (Ferromagnetic foreign bodies, pace-maker)
- •Claustrophobia
- •Women pregnant or Breast-feeding
- •Person with majority age protected by the law (supervision, trusteeship or under safeguard of justice).
- •Subject unable to understand the nature and the aim of the study and/or communication difficulties with investigator
- •Antecedent of serious cranial trauma (according to classification) of ischaemic stroke ou intracranial hematoma.
- •For the patients :
- •Antecedent of serious cranial trauma (according to classification), anterior or evolutive neurologic disease other than multiple sclerosis
- •Recent relapse of multiple sclerosis
- •For the healthy volunteers :
- •Antecedent of serious cranial trauma (according to classification), anterior or evolutive neurologic disease
- •Antecedent of neurological disease
- •In period of exclusion relative to another protocol or which the annual amount of the allowances maximum of 4500 € was reached.
研究组 & 干预措施
Progressive Multiple Sclerosis
22 patients with Progressive Multiple Sclerosis will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)
干预措施: Neuropsychological assessment (Other)
Progressive Multiple Sclerosis
22 patients with Progressive Multiple Sclerosis will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)
干预措施: Neurologic consultation (Other)
Progressive Multiple Sclerosis
22 patients with Progressive Multiple Sclerosis will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)
干预措施: MRIs (with vasoreactivity testing) (Other)
Multiple Sclerosis, Relapsing-Remitting
22 patients with Multiple Sclerosis, Relapsing-Remitting will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)
干预措施: Neuropsychological assessment (Other)
Multiple Sclerosis, Relapsing-Remitting
22 patients with Multiple Sclerosis, Relapsing-Remitting will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)
干预措施: Neurologic consultation (Other)
Multiple Sclerosis, Relapsing-Remitting
22 patients with Multiple Sclerosis, Relapsing-Remitting will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)
干预措施: MRIs (with vasoreactivity testing) (Other)
Healthy volunteers (22 patients)
22 healthy volunteers will be included and they get an Neuropsychological assessment and MRIs (with vasoreactivity testing)
干预措施: Neuropsychological assessment (Other)
Healthy volunteers (22 patients)
22 healthy volunteers will be included and they get an Neuropsychological assessment and MRIs (with vasoreactivity testing)
干预措施: MRIs (with vasoreactivity testing) (Other)
结局指标
主要结局
Cerebral vasoreactivity measured by diffusion imaging MRI (quantitative variable) :parameter which allow us to estimate the organization of the white matter tracts
时间窗: 2 months
次要结局
- Comparison of fonctional connective cards at Resting state(2 months)
- Cognitive disorders(2 months)