Traumatic Brain Injury Clinical Trials Network

创伤性脑损伤临床试验网络

• 批准号: 6655082
• 负责人: Jay Merlin Meythaler
• 金额: $ 36.84万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-05 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6655082
• 关键词: amantadine; behavior test; brain injury; cerebrospinal fluid; chemotherapy; clinical trials; cooperative study; dopamine; dopamine agonists; functional ability; growth factor; health care cost /financing; hematology; human subject; human therapy evaluation; longitudinal human study; medical rehabilitation related tag; patient oriented research; psychological tests; rehabilitation; serology /serodiagnosis; trauma

DESCRIPTION (provided by applicant): Traumatic brain injury (TBI) is one of the most significant causes of disability to able bodied persons in the most productive period of their lives. The most common cause is high-speed transportation accidents, and these result in a mechanism of injury commonly described as diffuse axonal injury (DAI). DAI causes a reduction in the turnover of dopamine in the brain. Basic science research has suggested that increasing dopamine turnover at the synaptic level may have a beneficial effect on recovery from brain injury. One medication, Amantadine, has been the subject of considerable interest and clinical use. It stimulates the release of dopamine from the presynaptic neuron, inhibits the re-uptake of dopamine, may directly interact with post-synaptic dopamine receptors and is a weak N-methyl-D-aspartate (NMDA) antagonist. The concept study proposed herein will evaluate the early clinical use of Amantadine in TBI. This concept study is supported by the outcomes of a pilot study performed at UAB. However, the definite beneficial effect of Amantadine on brain injury recovery has never been demonstrated. Considering the widespread clinical application of Amantadine in TBI patients, a well-controlled prospective multicenter clinical trial should be carried out. This concept study, or any other(s) selected, will contribute to the multicenter TBI Clinical Trials Network. As Amantadine is generically available, there is little interest in it by the private sector. The study design is a single case double blind, randomized controlled trial. Utilizing well established outcome measures, including behavioral and cognitive, the investigators will attempt to establish the efficacy and side effects of Amantadine in the acute stages of recovery from TBI. This research has the significant possibility of reducing the disability and economic burden of these patients.

描述（由申请人提供）：创伤性脑损伤（TBI）是在生命中最有生产力的时期，对身体有能力的人的残疾最重要的原因之一。最常见的原因是高速运输事故，这些事故导致了一种通常被描述为弥漫性轴突损伤（DAI）的损伤机制。 DAI导致大脑多巴胺的营业额减少。基础科学研究表明，在突触水平上增加多巴胺更新可能对脑损伤的恢复有益影响。一种药物Amantadine一直是兴趣和临床使用的主题。它刺激从突触前神经元中释放多巴胺，抑制多巴胺的再摄取，可能直接与后突触后多巴胺受体相互作用，并且是弱的N-甲基-D-天冬氨酸（NMDA）拮抗剂。本文提出的概念研究将评估tbi中阿曼达丁的早期临床使用。这项概念研究得到了在UAB进行的试点研究的结果。但是，从未证明阿甘丹丁对脑损伤恢复的明确有益作用。考虑到amantadine在TBI患者中的广泛临床应用，应进行良好控制的前瞻性多中心临床试验。该概念研究或所选的任何其他选择，将有助于多中心TBI临床试验网络。由于amantadine通常是可用的，因此私营部门对此几乎没有兴趣。研究设计是单案双盲，随机对照试验。利用良好的结局指标，包括行为和认知，研究人员将试图在从TBI恢复的急性恢复阶段中建立阿曼达丁的功效和副作用。这项研究具有减轻这些患者的残疾和经济负担的很大可能性。