BACKGROUND While many patients with mild traumatic brain injury (mTBI) or concussion recover completely, prolonged postconcussion symptoms remain a challenge for patients and an opportunity for clinical research. This has led to numerous research initiatives over the last 2 decades. OBJECTIVE To review the characteristics of clinical studies on management of mTBI/concussion; and to examine their definitions of mTBI/concussion. METHODS This scoping review included all clinical studies on diagnosis and management of patients with mTBI/concussion registered at www.clinicaltrials.gov from 2000 to June/2019. The terms "mild TBI/concussion" were used for the primary search. Definitions of mTBI/concussion were obtained from the protocols. When a definition was missing in the website, the study's investigators were contacted for clarification. RESULTS There were 225 interventional and 95 observational studies. Most of the studies are focused on treatment (54.7%) or diagnosis (37.5%), while 3.4% examined preventive measures, 2.8% evaluated prognostic instruments, and 1.6% developed registries. Most of the studies in this American database were single-center initiatives led by American and Canadian institutions. The definitions of mTBI/concussion differed widely among 109 studies. CONCLUSION The results of this review suggest that most of the clinical studies are focused on diagnosis and non-pharmacological therapies for patients with mTBI/concussion. The large number of differing definitions of mTBI/concussion among the studies creates significant limitations when comparing studies. The requirements for registering research protocols on mTBI/concussion should include the necessity to state the definition being used. There is a need for consensus on a uniform definition of concussion.

中文翻译：

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轻度创伤性脑损伤和脑震荡注册临床研究的范围审查（2000 年至 2019 年）

背景虽然许多轻度创伤性脑损伤 (mTBI) 或脑震荡的患者完全康复，但长时间的脑震荡后症状仍然是患者的挑战和临床研究的机会。在过去的 20 年里，这导致了许多研究计划。目的 回顾 mTBI/脑震荡管理的临床研究特征；并检查他们对 mTBI/脑震荡的定义。方法 本范围审查包括 2000 年至 2019 年 6 月在 www.clinicaltrials.gov 上注册的 mTBI/脑震荡患者的诊断和管理的所有临床研究。术语“轻度 TBI/脑震荡”用于初步搜索。mTBI/脑震荡的定义是从协议中获得的。当网站中缺少定义时，该研究' s 调查人员被联系以进行澄清。结果 共有 225 项干预性研究和 95 项观察性研究。大多数研究集中在治疗 (54.7%) 或诊断 (37.5%) 上，而 3.4% 检查预防措施，2.8% 评估预后工具，1.6% 开发登记。这个美国数据库中的大多数研究都是由美国和加拿大机构领导的单中心计划。mTBI/脑震荡的定义在 109 项研究中存在很大差异。结论 本综述的结果表明，大多数临床研究都集中在 mTBI/脑震荡患者的诊断和非药物治疗上。研究之间对 mTBI/脑震荡的大量不同定义在比较研究时产生了很大的局限性。注册 mTBI/脑震荡研究协议的要求应包括说明所使用定义的必要性。需要就脑震荡的统一定义达成共识。