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临床试验/NCT04055857
NCT04055857Unknown不适用

Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease: A Pioneer Multi-modal 7T MRI Observational Study.

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
fractional anisotropy (FA)

研究概览

简要总结

To discover the microstructure, macrostructure and functional changes with 7T multi-modal magnetic resonance imaging of Neuronal Intranuclear Inclusion Disease, and to explore new biomarkers for evaluating the severity and the progression of Neuronal Intranuclear Inclusion Disease.

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

入选标准

  • Patients diagnosed with NIID
  • Older than 18 years;
  • Sign the informed consent form.

排除标准

  • The informed consent is withdrawn by the subject;
  • Contraindications or intolerance to MRI: metallic foreign bodies, instability of vital signs, epilepsy, claustrophobia, etc.

结局指标

主要结局

fractional anisotropy (FA)

时间窗: 6 months

Parameters to describe integrity of white matter in diffusion MR Imaging

fiber number(fiber pass through the lesions)

时间窗: 6 months

Parameters to describe integrity of white matter in diffusion MR Imaging

Intracellular volume fraction(icvf)

时间窗: 6 months

Parameters to describe integrity of white matter in diffusion MR Imaging

mean diffusivity (MD)

时间窗: 6 months

Parameters to describe integrity of white matter in diffusion MR Imaging

orientation dispersion index (ODI)

时间窗: 6 months

Parameters to describe integrity of white matter in diffusion MR Imaging

short-range and long-range functional connectivity around the lesions at rest

时间窗: 6 months

Functional network connectivity impairments in patients

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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