Traumatic Brain Injury Clinical Trials Network

描述（由申请人提供）：这是“多中心创伤性脑损伤临床试验合作网络”中临床研究中心的修订提案。“该提案旨在与贝勒康复研究所（BIR）合作，在德克萨斯州达拉斯建立一个创伤性脑损伤（TBI）研究中心，总部设在帕克兰纪念医院（PMH）。这两个机构都是全国公认的神经外科，神经和康复护理。帕克兰是德克萨斯州北部地区主要的一级创伤中心，为大约500万人口提供服务。PMH平均每年约有350例TBI入院，其中140例为中度至重度脑损伤。所有TBI患者都由物理医学和康复服务进行评估，并获得适当的康复随访。绝大多数患者被转介到两个康复单位之一，即PMH和BIR的康复单位。BIR的帕克兰康复单位和TBI单位都是这个项目的合作者。主要研究者尤金·乔治博士是PMH神经外科服务部主任。他在TBI、蛛网膜下腔出血和脊髓损伤的多中心合作试验方面有经验。该项目的其他合作者都对TBI患者的护理有学术和临床承诺。Lisa-Ann Wuermser博士是PMH物理医学和康复服务的主任，也是SCI和TBI试验的积极研究者。玛丽卡莱尔博士是在BIR的TBI项目主任，并被广泛认可的卓越管理这些病人。Ramon Diaz-Arrastia博士是一位神经学家和临床神经生理学家，对脑损伤的机制感兴趣。 Munro Cullum博士是UT Southwestern的神经心理学主任，在TBI和其他神经退行性疾病方面有着广泛的成功合作研究记录。 纳入本提交文件的概念提案旨在确定连续视频EEG（CVEEG）监测在中重度至重度TBI患者中的有效性和价值。最近的技术进步使这成为可能，小型非对照研究表明，相当一部分TBI患者有轻微的非惊厥性癫痫发作（NCS），除非进行CVEEG，否则无法识别。该概念提案旨在确定NCS的积极治疗是否会改善功能结局。

DESCRIPTION (provided by applicant): This is a revised proposal for a Clinical Site in the "Cooperative multicenter traumatic brain injury clinical trials network." The proposal aims to establish a Traumatic Brain Injury (TBI) Research Center in Dallas, Texas, to be based at Parkland Memorial Hospital (PMH), with the collaboration of the Baylor Institute for Rehabilitation (BIR). Both institutions are nationally recognized for neurosurgical, neurological, and rehabilitation care. Parkland is the major Level I Trauma Center in the North Texas area, serving a population of approximately 5 million. PMH averages approximately 350 admissions for TBI each year, and 140 of these are for moderately severe to severe brain injury. All TBI patients are evaluated by the Physical Medicine and Rehabilitation service, and appropriate rehabilitation follow-up is obtained. The great majority of patients are referred to one of two rehabilitation units, the rehabilitation unit at PMH and BIR. Both the Parkland rehabilitation unit and the TBI unit at BIR are collaborators on this project. The PI, Dr. Eugene George, is Chief of the Neurosurgical Service at PMH. He has experience in multicenter collaborative trials in TBI, subarachnoid hemorrhage, and spinal cord injury. The other collaborators in the project all have an academic and clinical commitment to the care of patients with TBI. Dr. Lisa-Ann Wuermser is director of the Physical Medicine and Rehabilitation service at PMH, and an active investigator on trials on SCI and TBI. Dr. Mary Carlile is director of the TBI Program at BIR, and is widely recognized for excellence in management of these patients. Dr. Ramon Diaz-Arrastia is a neurologist and clinical neurophysiologist who is interested in the mechanisms of brain injury. Dr. Munro Cullum is Director of Neuropsychology at UT Southwestern, and has an extensive record of successful collaborative research in TBI and other neurodegenerative diseases. The concept proposal incorporated into this submission aims to determine the efficacy and value of continuous video-EEG (CVEEG) monitoring in patients with moderately-severe to severe TBI. Recent technical advances have made this possible, and small uncontrolled studies indicate that a significant fraction of patients with TBI have subtle nonconvulsive seizures (NCS), that would not be recognized unless CVEEG is performed. The concept proposal aims to determine whether aggressive treatment of NCS results in improved functional outcome.