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临床试验/NCT03034031
NCT03034031招募中不适用

Classifying Neuro-imaging Measures Predicting Rehabilitation Outcome Following Pediatric Closed Head Injuries.

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Functional MRI

研究概览

简要总结

This project will combine the data collected from structural and functional MRI scans and neuropsychology performance post-TBI in children. Patients will be followed for a year, in order to examine the brain and cognitive recovery post head injury.

详细描述

Traumatic brain injury in childhood has an cumulative effect that leads to impairments in cognitive functions such as deficits in memory, executive functions and attention. The cognitive impairment is the main cause of disabilities in the injured population, and has a different effect depending on the type and severity of the injury.

Imaging after brain trauma serves as a useful diagnostic tool in identifying the head trauma's results. Therefore, in recent years, using imaging methods, studies have tried to find measures which will be able to predict the functional outcome after brain injury in children, and assist in developing a personalized rehabilitation program. The combination of advanced imaging techniques with neuropsychological assessment within the early stage of the injury and during a year of followup, will allow us to establish the relationship between those measures and the functional recovery result of the children. This multi-analysis will enable us to have a deeper understanding of the neuroplasticity process and the functional recovery after brain injury in the developing young brain.

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

入选标准

  • Patients 9-18 years old, which are/were hospitalized in the Pediatric Rehabilitation Department, Sheba Medical Center
  • Glasgow coma scale score of 3-
  • Hebrew as mother-tongue

排除标准

  • History of neurological disorders, mental retardation or a previous head injury.
  • Current diagnosis or history of psychiatric disorders.
  • Cardiovascular instability.
  • Metabolic instability (water, electrolytes, sugar).
  • Fever or evidence of microbiological pollutant.
  • Uncontrolled seizures. 7 . Hydrocephalus.
  • Deafness or blindness.
  • Renal failure.

结局指标

主要结局

Functional MRI

时间窗: 12 months

fMRI brain activation to a cognitive tasks

Structural MRI

时间窗: 12 months

MRI Structural changes using different methods

neuropsychological tests

时间窗: 12 months

Cognitive scores on neuropsychological testing

次要结局

  • Associations between the cognitive performance and the imaging methods(12 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Abigail livny-ezer

Head of functional neuromaging lab, Department of Diagnostic Imaging

Sheba Medical Center

研究点 (1)

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