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临床试验/NCT00743821
NCT00743821已完成不适用

Eye-Tracking Rapid Attention Computation

Brain Trauma Foundation1 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
426
试验地点
1

研究概览

简要总结

The purpose of this study is to validate and refine a diagnostic device that can detect attention and memory deficits that result from mild traumatic brain injury (mTBI).

详细描述

The main goal of this project is the development of a military-ready, sensitive and rapid eye tracking diagnostic device for individuals with mild traumatic brain injury (mTBI). The device will also be tested for its efficacy in diagnosing fatigue and identifying aging effects. We will use a predictive visual tracking paradigm to dynamically capture the attentional state and correlate the subject's performance with the degree of disruption in the attention network caused by mTBI, aging and fatigue. The device will be tested for its diagnostic capabilities based on its selectivity, reliability, sensitivity and validity for individuals of varying ages (with and without mTBI) and in military personnel who have undergone 26 hours of sleep deprivation.

Testing will be conducted at two sites:

  1. Civilians with mTBI; and civilians with adult attention deficit hyperactivity disorder will be tested by trained staff of the Brain Trauma Foundation (BTF) at Weill Cornell Medical College (WCMC) in New York City. The ages of the enrolled individuals will range between 18-55 years in order to examine aging effects.
  2. Enrolled service members will be tested at the United States Army Research Institute of Environmental Medicine (USARIEM) in Natick, Massachusetts. These service members will be healthy volunteers without a history of mTBI. Some of these subjects will undergo 26 hours of sleep deprivation during which they will be tested at specific time points.

Our objectives are:

  1. Prove that the eye-tracking concept can be brought from a successful laboratory device to a specific, reliable, selective, and valid diagnostic tool.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteer
  • Education up to 12th grade

排除标准

  • History of concussion or TBI
  • Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)
  • Gross visual or hearing problems
  • Pregnancy
  • Metal in the body or any contraindications for MRI
  • TBI Patients:
  • Inclusion Criteria:
  • Education up to 12th grade
  • Persistent post concussive symptoms after an isolated incident of head injury with or without loss of consciousness between 3 months to 5 years prior to participation
  • Exclusion Criteria
  • Prior history of seizures
  • Pregnant woman
  • Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)
  • Gross visual or hearing problems
  • Any metal in the body or contraindications for MRI

研究者

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

Jamshid Ghajar, M.D., Ph.D.

President

Brain Trauma Foundation

研究点 (1)

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