NCT00580918撤回不适用
Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- fMRI scans
研究概览
简要总结
The purpose of this study will be to assess the attentional ability of patients with mild to moderate traumatic brain injury (TBI) using the functional Magnetic Resonance Imaging (fMRI) technique. Methodology for specific aim 1: sagittal pilot scan, 3-D anatomical MRI, Whole brain echo-planar imaging (EPI), and functional MRI techniques with traumatic brain injured subjects doing a Continuous Performance Test (CPT) attention task and compare the pattern of activation with those of normal controls to see if there is a failure to activate frontal lobes in the traumatic brain injured subjects.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild to moderate brain injury patients referred to the UCI Brain Imaging Center.
- •Mild brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 13-
- •Moderate brain injury brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 9-12 .
- •Normal healthy control subjects (20)
排除标准
- •Pre-accident neuropathology, psychopathology, or secondary neuropathological complications, or chemical abuse
- •Patients who required intracranial surgical intervention
- •Children, pregnant women, or institutionalized individuals unable to freely give consent
- •Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material
- •Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities
- •Patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported)
- •Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion
- •Patients with implanted prosthetic heart valves
- •Patients with pacemakers, neuro-stimulation devices
- •Subjects who have severe claustrophobia.
结局指标
主要结局
fMRI scans
时间窗: three to four years post injury
次要结局
未报告次要终点
研究者
研究点 (1)
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