Eval, Pathogenesis, Outcome of Subjects with or Suspected Traumatic Brain Injury

每年，至少有140万人患有TBI，超过110万人接受治疗并从急诊科（艾德）出院。大约有125，000名TBI患者，通常是那些受伤更严重的患者，由于大脑损伤而导致永久性残疾。另一方面，轻度TBI（占所有TBI的至少75%）导致更微妙的功能和认知缺陷，这些缺陷在急性环境中通常未被发现。这些患者的生活质量可能会发生剧烈变化，难以恢复日常活动，可能数周或数月无法恢复工作。据估计，仅轻度TBI每年就花费美国超过170亿美元的长期护理和生产力损失。 缺乏用于诊断和分类急性TBI的客观标准对开发治疗和提供统一质量的护理提出了重大障碍。有头部损伤史的患者通常在艾德接受使用计算机断层扫描（CT）的筛查性脑部扫描，尽管检测轻度损伤的灵敏度较低。 大多数直接从艾德出院的患者被诊断为脑震荡，尽管存在持续和复杂的脑震荡后综合征，包括头痛、头晕、注意力受损、注意力难以集中、记忆力差和情绪问题，但他们还是雅阁寻求进一步的医疗支持。 该项目的目的是生成自然病史数据，用于基于队列的比较，以作为未来假设驱动方案的基础，并通过描述损伤的表现以及放射学、血液学、临床变量和标准功能/认知结果测量之间的关系，促进对创伤性脑损伤（TBI）的临床和生理学理解。 这是一项在已知和疑似非穿透性急性创伤性脑损伤受试者中进行的前瞻性研究，这些受试者入组了两项IRB批准的方案之一。 使用放射学、血液学、临床和功能/认知结果测量，在参与医院的急诊科或创伤服务中对具有近期头部损伤史的受试者在其住院期间和出院后进行研究。 除了到我们当地医院接受急诊治疗的患者外，还可以选择从当地医院以外招募受试者，将其带到NIH临床中心进行更全面的评估和转诊到其他研究。 将根据结果将受试者分层至队列中进行比较。该设计有意扩大范围，以允许获取用于开发未来假设驱动方案的初始数据。根据本方案进行的研究不会干扰标准治疗，受试者不会接受作为研究一部分的实验性治疗。如果受试者在知情同意书上批准此选项，则可以与其他研究者共享本研究中收集的数据，而不使用个人标识符。 迄今为止，已招募了1，000多名近期头部损伤伴或疑似非穿透性急性TBI的成人受试者。 将从NIH和非NIH医院之间的合作项目中招募具有不同程度TBI严重程度的受试者。 大约80%的受试者被归类为轻度TBI、脑震荡或无损伤，大约一半的受试者直接从急诊科出院。 受试者可以选择来NIH临床中心进行超高场（7 T）成像，使用正电子发射断层扫描（PET）成像，或在合作项目下进行长达5年的随访。 该项目是NIH统一服务大学-神经科学和再生医学中心（CNRM）的一部分。 作为这种合作的一部分，重点是改善我们的军事服务成员的结果，正在开发治疗急性到慢性时间范围内的患者的疗法。 我们已经发现脑膜和脉管系统的损伤与创伤后头痛和相关的躯体感觉缺陷的发展有关。 目前正在利用该项目收集的数据，帮助设计一项研究，以在急性护理环境中对创伤后头痛进行治疗。

Each year, at least 1.4 million people sustain TBI, with over 1.1 million treated and released from the emergency department (ED). Approximately 125,000 patients with TBI, typically those more severely injured, experience permanent disability as a result of damage to the brain. On the other hand, mild TBI, accounting for at least 75% of all TBI, results in more subtle functional and cognitive deficits that often go undetected in the acute setting. These patients can experience drastic changes in their quality of life, have difficulties returning to daily activities and may be unable to return to work for weeks or months. It is estimated that mild TBI alone costs the United States in excess of $17 billon per year in long-term care and lost productivity. Lack of objective criteria for diagnosing and classifying acute TBI presents a significant impediment to developing therapies and to providing uniform quality of care. Patients with a history of head injury often receive a screening brain scan using computed tomography (CT) in the ED despite a low sensitivity for detecting mild injury. The majority of patients discharged directly from the ED are assigned the vague diagnosis of concussion and left to their own accord to seek further medical support, despite a persistent and complex post concussive syndrome that includes complaints of headaches, dizziness, impaired attention, trouble concentrating, poor memory, and emotional problems. The objective of this project is to generate natural history data for cohort-based comparisons to serve as the basis for future hypothesis-driven protocols and to contribute to the clinical and physiological understanding of traumatic brain injury (TBI) through the description of manifestations of the injury and the relationship among radiological, hematological, clinical variables and standard functional/cognitive outcome measures. This is a prospective study of subjects with known and suspected non-penetrating acute traumatic brain injury who are enrolled in one of two IRB approved protocols. Subjects presenting to the emergency department or trauma service at participating hospitals with a history of recent head injury are studied during the course of their hospital stay and after discharge using radiological, hematological, clinical and functional/cognitive outcome measures. In addition to patients presenting to our local hospitals for acute care, there is an option to recruit subjects from beyond the local hospitals to be brought to the NIH Clinical Center for a more comprehensive battery of assessments and referral to other studies. Subjects will be stratified according to findings into cohorts for comparison. The design is intentionally broad in scope to allow acquisition of initial data for the development of future hypothesis-driven protocols. Research performed under this protocol will not interfere with standard of care and subjects will not be treated with experimental therapies as part of the research study. Data collected under this research study may be shared without personal identifiers with other researchers if subjects approve this option on the informed consent. To date, more than 1,000 adult subjects with history of recent head injury with or suspected non-penetrating acute TBI have been enrolled. Subjects having varying degrees of TBI severity will be recruited from the collaborative programs between NIH and non-NIH hospitals. Approximately 80% of subjects are classified as mild TBI, concussion, or no injury, with approximately one half of subjects enrolled being discharged directly from the emergency department. Subjects are offered the option of coming to the NIH clinical center to be imaged at very high fields (7T), imaged with positron emission tomography (PET), or followed for up to 5 years under a collaborative project. The project is part of the NIH Uniform Services University - Center for Neuroscience and Regenerative Medicine (CNRM). As part of this collaborative with a focus of improving outcomes in our military service members, therapies are being developed to treat patients spanning the acute to chronic time frames. We have discovered injury to the meninges and vasculature that is implicated in the development of post-traumatic headache and related somatosensory deficits. Work is under way using data collected under this project to help design a study to prophylactically treat the post-traumatic headache in the acute care setting.