Prognostic Value of MR Imaging Markers in the Assessment of Traumatic Brain Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Identification of advanced MR imaging markers
研究概览
简要总结
This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients.
It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.
详细描述
The goal of this study is to identify advanced magnetic resonance imaging markers that can serve as a prognostic marker in the evaluation and management of traumatic brain injury patients.
Magnetic resonance imaging and cognitive testing (when possible) will be performed in the acute (within 10 days following injury), and recovery stages (about 1 month, about 6 months,and about 18 months). The relationship between the advanced magnetic resonance imaging markers and the clinical condition of the patient will be evaluated at each time point to determine which combination of imaging markers best describe the current clinical status of the patient and which markers best predict a patient's outcome status.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status.
- •Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments.
排除标准
- •History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease.
- •History of Stroke
- •History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type.
- •History of Brain Tumor
- •Status post trauma due to asphyxiation
- •Preexisting contraindications for Magnetic Resonance Imaging (MRI)
- •Active Duty Military Status
- •Police custody or prisoner status
- •Pregnant women
结局指标
主要结局
Identification of advanced MR imaging markers
时间窗: 18 months post-injury
Systematically study the imaging markers obtained from novel MRI techniques (diffusion tensor imaging (DTI), susceptibility-weighted imaging (SWI), MR spectroscopy, resting state MRI, and arterial spin labeling) and assess the markers for sensitivity.
次要结局
- extent of disability(18 months post-injury)
- level of orientation(18 months post-injury)
- level of cognitive function(18 months post-injury)
- level of functional independence(18 months post-injury)
研究者
Rao P Gullapalli
Professor
University of Maryland, Baltimore