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临床试验/NCT00653029
NCT00653029终止不适用

An fMRI Study of Selective Attention, Working Memory, and Effort After Mild Traumatic Brain Injury

State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
12
试验地点
1
主要终点
BOLD Response

研究概览

简要总结

Approximately 1.1 million people a year suffer a mild traumatic brain injury (MTBI), or concussion, in the United States. Although most MTBI patients fully recover, as many as 28% have physical, cognitive, and/or emotional symptoms up to 6 months post-injury. When symptoms persist past three months, it is known as post-concussion syndrome (PCS). The cause of PCS is unknown, as structural neuroimaging and neuropsychological (NP) testing results are often normal. However, recent functional magnetic resonance imaging (fMRI) research in concussed adults showed differences in brain activity compared to controls on working memory tasks, despite normal structural MRI and neuropsychological findings. We propose improving this research by assessing brain activation patterns during simple versus complex attention and working memory tasks in 10 concussed adults via fMRI. This will be the first study to examine brain activation patterns associated with the degree of effort applied to testing, a factor known to confound interpretation of NP test performance. Validated computerized measures of selective attention (Modified Stroop Interference Task), working memory (n-back), and effort (Green's Medical Symptom Validity Test; MSVT) will be used. Ten paid controls will be used for comparative purposes. We hypothesize that concussed patients will show less brain activation than controls on complex versus simple working memory tasks and that activation patterns in concussed patients will generally be lower in those with suboptimal effort. We will also characterize self-reported emotional and physical symptoms in the PCS patients, which has not been done in prior fMRI research with this population.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Mild TBI (based on criteria of the American Congress of Rehabilitation Medicine)
  • Aged 18 to 60
  • History of non-penetrating head injury
  • Obtaining medical assistance (e.g., personal physician, Emergency Room) within 24 hours post-injury

排除标准

  • No prior history of prior post-concussion syndrome (i.e, uncomplicated mild TBI)
  • Moderate to severe TBI
  • Substance dependence
  • Learning disorder
  • Attention-deficit disorder
  • Mental retardation
  • Severe psychiatric disorder requiring hospitalization
  • Previous central nervous system disease
  • Absence of neurosurgery
  • No evidence of alcohol/drug use related to the injury

结局指标

主要结局

BOLD Response

时间窗: Patients will undergo fMRI at least one month after injury

Blood Oxygen Level Dependent Response protocol on fMRI

次要结局

未报告次要终点

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Rieger

Chief Psychologist PM&R

State University of New York - Upstate Medical University

研究点 (1)

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