跳至主要内容
临床试验/NCT04145414
NCT04145414已完成不适用

Cerebrospinal Fluid Movements Through Interventricular Foramina in Phase Contrast Magnetic Resonance Imaging (PC-MRI)

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
PC-MRI procedure reproductibility

研究概览

简要总结

Assess the reproductibility of PC-MRI for cerebrospinal fluid movements through the interventricular foramina on volunteer subjects.

详细描述

It is a monocentric interventional prospective study. Each subject will have to pass two MRI. Phase contrast MRI (PC-MRI) will be calibrated for each subject by assessing the optimal encoding velocity. Three sequences including the aqueduct and the two interventricular foramina (IVF) will be done. The signal will be analysed by syngo.via software after defining by two different investigators the region of interest (ROI) which correspond to the IVF or the aqueductal lumen. Descriptive statistics will test the intra-individual and inter-observer consistency based on 4 flow parameters.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Mini-Mental State Examination score > 28/30

排除标准

  • MRI contraindication
  • Medical or surgical history related to following pathologies: nervous system disease, cardiac arrhythmia, cardiac or respiratory insufficiency.
  • Long-term medical treatment
  • Ongoing pregnancy

结局指标

主要结局

PC-MRI procedure reproductibility

时间窗: week 6

Test-retest reproducibility of double measures (2nd measure at +48 hours minimum +6 weeks maximum) of 4 cerebrospinal liquid (CSL) flow parameters during PC-MRI. CSL flow through interventricular foramina will be measured within healthy volunteers, and 4 intraclass correlation coefficients (ICC) will be calculated. The test-retest coefficient will be considered satisfactory if \> or = to 0.75 .

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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