NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Neurotrauma and Ophthalmology Research Group, Institute of Inflammation and Aging, University of Birmingham, Birmingham, UK.
BMJ Open. 2019 Jul 4;9(7):e029883. doi: 10.1136/bmjopen-2019-029883.
Sport-related concussion management remains a diagnostic dilemma to clinicians in all strata of care, coaching staff and players alike. The lack of objective diagnostic and prognostic biomarkers and over-reliance on subjective clinical assessments carries a significant health risk of undiagnosed concussive episodes and early return to play before full recovery increasing the risk of sustaining additional concussion, and leading to long-term sequelae and/or unfavourable outcome.
To identify a set of parameters (neuroimaging with neurophysiological, biological and neuropsychological tests) that may support pitch-side and outpatient clinical decision-making in order to objectively diagnose concussion, determine the severity of injury, guide a safe return to play and identify the potential predictors of the long-term sequelae of concussion.
An exploratory, observational, prospective, cohort study recruiting between 2017 and 2020. The participants will have a baseline preseason screening (brain imaging, neuropsychological assessments, serum, urine and saliva sampling). If a screened player later suffers a concussion and/or multiple concussions then he/she will be assessed again with the same protocol within 72 hours, and their baseline data will be used as internal control as well as normative data. Inferential statistical analysis will be performed to determine correlations between biological, imaging techniques and neuropsychological assessments.
This study was approved by the East of England-Essex Research Ethics Committee on 22 September 2017-REC 17/EE/0275; IRAS 216703. The results of this study will be presented at national and international conferences and submitted for publication in peer reviewed journals.
ISRCTN16974791; Pre-results.
运动相关性脑震荡的管理对各级医护人员、教练人员和运动员来说都是一个诊断难题。缺乏客观的诊断和预后生物标志物,过度依赖主观的临床评估,这带来了未被诊断出的脑震荡发作和在完全康复前过早重返赛场的重大健康风险,增加了遭受额外脑震荡的风险,并导致长期后遗症和/或不良后果。
确定一组参数(神经影像学与神经生理学、生物学和神经心理学测试),以支持现场和门诊临床决策,从而客观地诊断脑震荡,确定损伤严重程度,指导安全重返赛场,并确定脑震荡长期后遗症的潜在预测因素。
这是一项探索性、观察性、前瞻性队列研究,招募时间为 2017 年至 2020 年。参与者将进行基线赛季前筛查(脑成像、神经心理学评估、血清、尿液和唾液取样)。如果筛查后的运动员后来遭受脑震荡和/或多次脑震荡,那么他/她将在 72 小时内再次接受相同的方案评估,他们的基线数据将用作内部对照和正常值。将进行推断性统计分析,以确定生物学、成像技术和神经心理学评估之间的相关性。
这项研究于 2017 年 9 月 22 日获得了东英格兰埃塞克斯研究伦理委员会的批准 - REC 17/EE/0275;IRAS 216703。该研究的结果将在国家和国际会议上展示,并提交给同行评审期刊发表。
ISRCTN86505174;预结果。