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临床试验/NCT01980186
NCT01980186Unknown不适用

Transcranial Ultrasonography Using Linear 2D Imaging of the Brain and Surrounding Tissues

Brain Treatment Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Extra-axial fluid as measured at the gyral summit.

研究概览

简要总结

This study will use linear 2D ultrasound imaging to look at the brain of individuals diagnosed with autism and their siblings. This is called transcranial ultrasound (TUS). It is hypothesized that TUS will allow real-time imaging of the fluid spaces outside the brain and will further allow the imagining of brain areas important to language and social function.

详细描述

TUS will be evaluated as a simple and low cost screening technique to evaluate the presence of increased extra-axial fluid (EAF)or(subarachnoid cerebral spinal fluid). A recent study (Shen et al. 2013) demonstrated increased EAF was predictive of risk of autism. We believe TUS is capable or rapid, safe, low cost, non-invasive measurement of EAF spaces. Where prior imaging, ie., MRI or CT exist they will be used as comparisons. Both individuals with autism and their siblings will be screened to create a database and standard for TUS measurements. It is further believed that TUS may be able to detect areas of cortical abnormalities called dysplasias. The procedure requires no sedation and only takes a few minutes to perform. If validated, this would make TUS an ideal screening test for autism risk and allow for early referral and more definitive imaging with MRI where necessary.

研究设计

研究类型
Observational

入排标准

年龄范围
6 Months 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of autism or the sibling thereof and willingness of a parent to consent and where applicable for the individual to assent or consent depending on age.

排除标准

  • Siblings must have no obvious health issues or developmental abnormalities.

结局指标

主要结局

Extra-axial fluid as measured at the gyral summit.

时间窗: This study will collect data for up to 3 years to determine the accuracy of the predictive assessments for autism risk

TUS is performed with linear 2D acoustical outputs in the 10-5MHz range. These are typical for TUS investigations with doppler and the only difference is the linear output of the probe.

次要结局

未报告次要终点

研究者

发起方
Brain Treatment Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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