跳至主要内容
临床试验/NCT03356366
NCT03356366进行中(未招募)不适用

Magnetic Resonance Imaging Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70
试验地点
2
主要终点
Measurement of the Expanded Disability Status Scale (EDSS) value (score from 0 to 20) constituing the actual international reference scale to measure the level of disability caused by parkinson disease

研究概览

简要总结

Multiple sclerosis (MS) is the first non-traumatic cause of disability in young people, responsible for physical but also cognitive deficits. MS is an inflammatory demyelinating and degenerative disease of the central nervous system. Recently, MRI technics have demonstrated their sensibility to the different processes involved in MS. Particularly, MRI has evidenced that the pathological process of MS is not restricted to the macroscopic lesions of the white matter but also involves the normal appearing white and grey matter. In the normal appearing brain tissue, demyelination, neuronal suffering and neuronal loss have been evidenced. Moreover, MRI has demonstrated the existence of brain functional reorganization processes that may limit the clinical expression of pathological injuries. Despite these important findings, the pathological underpinnings of irreversible disability are largely unknown. The present project aims to depict the main determinants of physical but also cognitive disability in patients with MS. To do this, a longitudinal study including 70 patients with MS using different MRI markers known to be sensitive to the different pathological aspects of MS will be performed. The relationships between these markers and the progression of disability will be assessed. Identification of the main pathological underpinnings of irreversible disability of MS will provide the most relevant therapeutic targets.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major patient,
  • Patient affiliated to a health insurance plan
  • Patient having signed free and informed consent after receiving detailed, understandable and honest information,
  • Patient with multiple sclerosis according to the criteria of Polman 2010

排除标准

  • Patients with the usual contraindications to MRI (pace-maker, agitation, metal splinters, claustrophobia etc.)
  • Patients at risk of non-compliance on examination: impaired understanding, confusion, involuntary movements, poor tolerance of prolonged supine
  • Patients with known allergy to gadolinium
  • Patients with renal insufficiency
  • Patients unable to give their consent: disorders of the comprehension, disturbances of vigilance, confusion ...
  • Pregnant and breastfeeding woman
  • Patients with a history of neurological or psychiatric pathology
  • Patients under guardianship or curatorship

结局指标

主要结局

Measurement of the Expanded Disability Status Scale (EDSS) value (score from 0 to 20) constituing the actual international reference scale to measure the level of disability caused by parkinson disease

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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