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临床试验/NCT04405128
NCT04405128Unknown不适用

Brain TV (Tissue Velocimetry) for Emergency Assessment of Acquired Brain Injury

University of Leicester1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
1
主要终点
MRI measurement

研究概览

简要总结

This study uses a Doppler ultrasound technique being developed at the University of Leicester called 'Brain Tissue Velocimetry" (Brain TV), to investigate brain tissue motion over the cardiac cycle.

详细描述

Brain motion is highly sensitive to heart and brain biomechanics, but the impact of brain injury on brain tissue motion has yet to be explored. Preliminary brain tissue motion measurements from a small number of patients suggest that brain biomechanics may be disturbed in the presence of injury. This study combines Transcranial Tissue Doppler ultrasound with brain MRI to establish whether analysis of brain tissue motion provides clinically useful information for emergency diagnosis and monitoring of acute brain injury.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Participant (or consultee) is willing and able to give informed consent (or assent) for participation in the study.
  • Adult, aged 18 years or over.
  • Suspected Acquired Brain Injury (any severity).

排除标准

  • Unable (in the investigators' opinion), or unwilling, to comply with the study requirements.
  • Patients with pre-existing chronic brain conditions that may make affect informed consent, such as severe learning difficulties, dementia, or Alzheimer's disease, will be excluded.

结局指标

主要结局

MRI measurement

时间窗: Up to 5 days.

This study will perform brain MRI for brain tissue motion for selective patients with suspected stroke.

TCTD measurement

时间窗: Up to 5 days.

The study will generate a library of Brain TV measurements for exploratory (descriptive) analysis and imaging of brain tissue pulsations in patients with suspected stroke to evaluate the potential for clinical device development.

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 (1)

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