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临床试验/NCT02688660
NCT02688660已完成不适用

MRI Markers of Outcome After Severe Pediatric Traumatic Brain Injury (TBI)

University of Wisconsin, Madison21 个研究点 分布在 3 个国家目标入组 82 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
21
主要终点
White matter fractional anisotropy

研究概览

简要总结

Traumatic brain injury (TBI) is the leading cause of death or disability in children. Each year in the United States, pediatric TBI results in an estimated 630,000 emergency room visits, 58,900 hospitalizations, and 7000 deaths. The incidence of long-term disability after severe TBI is high, with over 60% of children requiring educational or community based supportive services 12 months post-injury. Over 5,000 children require inpatient rehabilitation after TBI each year and an estimated 145,000 US children are currently living with disabilities after a severe TBI. Hospital costs for the acute treatment of children with TBI are estimated at ~$2.6 billion each year, while the gross annual costs accounting for long-term care and lost productivity approach $60 billion. Therefore, pediatric TBI is a major public health concern and new ways to diagnose and treat TBI are urgently needed.

详细描述

Severe pediatric TBI results in a range of neurocognitive and behavioral deficits with resultant impact on school performance, social functioning, and quality of life. Sixty percent of children suffer from long-term functional impairments after severe TBI, and more than 40% demonstrate deficits in multiple cognitive and psychological domains. Importantly, a recent meta-analysis revealed that rather than catching up to their peers in these domains, children with severe TBI fall further behind over time. These deficits in cognitive and emotional function have a major impact on the child's quality of life after a TBI. A large study recently reported that severe TBI patients demonstrated lower quality of life than children undergoing active treatment for cancer. Considerable variation exists in the severity of impairment within each cognitive domain from patient to patient, likely relating to the mechanism of injury, the type and location of lesion, patient age, and pre-morbid functioning among other factors. While clinical scales such as the Glasgow Coma Scale (GCS) are useful for assessing injury severity and may provide general prognostic information, they are insufficient to identify risk for specific cognitive deficits. Identifying predictors of impairment within specific domains would aid in directing rehabilitation strategies towards at-risk cognitive domains, thereby improving long-term function and quality of life.

The investigators are partnering with an ongoing pediatric TBI trial (ADAPT Trial: Approaches and Decisions in Acute Pediatric TBI) and will also be enrolling past UW patients and healthy controls. Consistency in timing of follow-up scans, large sample size and access to the ADAPT Trial injury severity data and neuropsychological testing will give this study unprecedented power to assess the relationship between early MRI findings and subsequent atrophy, white matter injury, network connectivity changes and neurocognitive and behavioral impairments.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • Aim 1 Subjects:
  • Children 0 through < 18 years of age
  • Diagnosis of severe TBI (defined as a Glasgow Coma Scale (GCS) score less than or equal to 8)
  • Had an intracranial pressure (ICP) monitor as part of standard care
  • Aims 2 & 3 Subjects:
  • Children 9 through < 18 years of age with severe TBI
  • Consent for a follow-up MRI within 10 years of the time of TBI
  • Healthy children greater than or equal to 9 and < 18 years of age.

排除标准

  • TBI & controls:
  • Anyone unable to tolerate a non-sedated MRI
  • Any history of head injury resulting in loss of consciousness
  • Standard contraindications to MRI (metallic implants, implanted electronic devices, pregnancy, etc.).

结局指标

主要结局

White matter fractional anisotropy

时间窗: 1 year

Fractional Anisotropy will be assessed using Diffusion Tensor MRI

Cerebral Atrophy

时间窗: 1 year

Global and regional cerebral atrophy will be assessed using MRI

Brain network connectivity

时间窗: 1 year

Network connectivity will be assessed using resting-state functional MRI

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 (21)

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