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临床试验/NCT01720979
NCT01720979已完成不适用

Attention, Learning and Behaviour Following Traumatic Brain Injury in Children

Marsh Königs5 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
5
主要终点
The white-matter integrity of children with TBI will be compared to children with traumatic control injuries

研究概览

简要总结

Traumatic Brain Injury (TBI) is the world leading cause of acquired brain injury. Literature suggests a pivotal role for attentional functioning in neurocognitive and behavioural consequences of paediatric TBI. Limitations of traditional neuropsychological measures of attentional functioning have interfered with identification of the effect of paediatric TBI on attentional networks so far. Moreover, the associations between attentional networks, learning abilities, academic performance and behavioural and emotional problems following paediatric TBI are yet to be explored.

详细描述

Background:

Traumatic brain injury (TBI) is the world leading cause of disability in children (Winslade, 1998), causing deficits in motor function, neurocognition and adaptive behaviour (Anderson, 2001). Literature shows that age at injury is inversely related to the magnitude of deficits following TBI, highlighting the vulnerability of children for the effects of TBI.

The neurocognitive consequences of paediatric TBI have primarily been characterized by impairments in speed of information processing, attentional functioning and learning (Babikian & Asarnow, 2009; Catroppa & Anderson, 2009), interfering with typical neurocognitive development. We aim at elucidating the effects of TBI on neurocognitive function and investigate the relations between neurocognitive deficits, academic achievement and emotional and behavioural function, in order to improve our understanding of the post-injury functioning of children that have suffered TBI.

Methods:

Patients with TBI will be compared to a control group consisting of orthopedically injured patients. Orthopaedic control (OC) groups offer a better comparison to TBI patients than typically developing children by controlling for TBI risk factors related to neurocognition (e.g. Attention Deficit Hyperactivity Disorder, socioeconomic status), hospitalisation and the type of injuries other than brain injuries.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • TBI patients will be included if they
  • have parental written informed consent
  • provide written informed consent if aged over 11 years
  • are Dutch speaking
  • have a clinical diagnosis of TBI (closed head injury)
  • have a time post-injury that is longer than 1 month
  • are aged between 6-12 years.
  • Trauma control patients will be included if they:
  • have parental written informed consent
  • provide written consent if aged over 11 years
  • are Dutch speaking
  • have suffered an orthopaedic injury
  • have no history of TBI
  • and are aged between 6-12 years.

排除标准

  • 未提供

结局指标

主要结局

The white-matter integrity of children with TBI will be compared to children with traumatic control injuries

时间窗: on average 1-year post-TBI

FA/ADC values will be reported for selected region's of interest in children with TBI and children with traumatic control injuries.

Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries

时间窗: on average 1-year post-TBI

Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries

次要结局

  • Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries(on average 1-year post-TBI)
  • Academic achievement will be compared between children with TBI and children with traumatic control injuries(on average 1-year post-TBI)
  • Performance on test of reinforced learning will be compared between children with TBI and children with traumatic control injuries(on average 1-year post-TBI)

研究者

发起方
Marsh Königs
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marsh Königs

MSc

VU University of Amsterdam

研究点 (5)

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