Translational Medicine and Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, United Kingdom.
Department of Stroke Medicine, London, Royal London Hospital, London, Barts Health NHS Trust, London, United Kingdom.
PLoS One. 2023 Dec 22;18(12):e0289719. doi: 10.1371/journal.pone.0289719. eCollection 2023.
Labile blood pressure after acute ischaemic stroke requiring mechanical thrombectomy is independently associated with poor patient outcomes.
This study protocol describes is designed to determine whether transauricular nerve stimulation, improves baroreflex sensitivity, reduces blood pressure variability in the first 24 hours after acute ischaemic stroke requiring mechanical thrombectomy.
PHASE 2A, PROOF-OF-CONCEPT, SHAM-CONTROLLED RANDOMISED TRIAL: Methods and Analysis: 36 individuals undergoing mechanical thrombectomy for acute ischaemic stroke with established hypertension aged >18 years will be randomly allocated to receive bilateral active or sham transauricular nerve stimulation for the duration of the mechanical thrombectomy procedure (AffeX-CT/001 investigational device). The intervention will be repeated for 1h the morning following the mechanical thrombectomy. Non-invasive blood pressure will be measured ≥2h for 24h after mechanical thrombectomy. Holter electrocardiographic monitoring will be recorded during transauricular nerve stimulation. Participants, clinicians and investigators will be masked to treatment allocations. The primary outcome will be the coefficient of variation of systolic blood pressure. Secondary outcomes include additional estimates of blood pressure variability and time/frequency-domain measures of autonomic cardiac modulation An adjusted sample size of 36 patients is required to have a 90% chance of detecting, as significant at the 5% level, a difference in the coefficient of variation in systolic blood pressure of 5±4mmHg between sham and active stimulation [assuming 5% non-compliance rate in each group]. Ethics: confirmed on 16 March 2023 by HRA and Health and Care Research Wales ethics committee (reference 23/WA/0013).
This study will provide proof-of-concept data that examines whether non-invasive autonomic neuromodulation can be used to favourably modify blood pressure and autonomic control after acute ischaemic stroke requiring mechanical thrombectomy.
Trial registration number: NCT05417009.
急性缺血性卒中并需要机械取栓的患者血压不稳定与较差的预后相关。
本研究旨在确定经耳神经刺激是否能改善压力反射敏感性，降低机械取栓后 24 小时内的血压变异性。
2A 期，概念验证，假对照随机临床试验：方法和分析：36 名年龄>18 岁并患有高血压的急性缺血性卒中并需要机械取栓的患者将被随机分配接受双侧经耳神经刺激（AffeX-CT/001 研究设备）或假刺激，持续进行机械取栓手术。在机械取栓后第二天早晨，将重复该干预措施 1 小时。机械取栓后 24 小时内，非侵入性血压监测至少 2 小时。经耳神经刺激时进行动态心电图监测。参与者、临床医生和研究人员将对治疗分配进行盲法。主要结局为收缩压变异系数。次要结局包括血压变异性的其他评估指标以及自主心脏调节的时频域指标。需要 36 名患者的调整样本量，才能有 90%的机会在 5%的水平上检测到假刺激和真刺激组之间收缩压变异系数的差异为 5±4mmHg[假设每组的不依从率为 5%]。
2023 年 3 月 16 日，经 HRA 和威尔士健康与保健研究伦理委员会确认（参考号 23/WA/0013）。
本研究将提供概念验证数据，以检验非侵入性自主神经调节是否可用于改善急性缺血性卒中并需要机械取栓的患者的血压和自主控制。
试验注册号：NCT05417009。
