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临床试验/NCT06335004
NCT06335004进行中(未招募)不适用

Valutazione Delle Vie "Glinfatiche" Utilizzando la Risonanza Magnetica Nelle Malattie Della Sostanza Bianca

IRCCS Eugenio Medea1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月1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)
发起方
入组人数
100
试验地点
1
主要终点
Extent of white matter lesions

研究概览

简要总结

The dilation of perivascular spaces can be the result of various etiopathogenetic processes. White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies. Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. Dilation of PVS can be associated with changes in white matter and microhemorrhages. We want to study these etiopathogenetic phenomena by implementing specific MRI methods.

详细描述

Primary objective: the quantification of indirect magnetic resonance markers of altered waste drainage systems using validated scales in patients with white matter disease. Secondary objective: the evaluation of white matter alterations in relation to the known anatomical glymphatic pathways by analyzing both structural and diffusion data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
9 Months 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with and without white matter disease
  • patients willing to participate in research with signed consent form
  • no age limit (results will be age matched)

排除标准

  • unwilling to participate in research

结局指标

主要结局

Extent of white matter lesions

时间窗: once at recruitment

T1 values of lesions

Number of perivascular spaces

时间窗: once at recruitment

count of perivascular spaces and total volume in disease population

Volume of parasagittal dural space

时间窗: once at recruitment

volume of parasagittal dural space in disease population

次要结局

未报告次要终点

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (1)

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