Gauthey Anaïs, Morra Sofia, van de Borne Philippe, Deriaz Denis, Maes Nathalie, le Polain de Waroux Jean-Benoît
Department of Cardiology, Saint-Luc Hospital, Université catholique de Louvain, Brussels, Belgium.
Department of Cardiology, Erasme Hospital, Université libre de Bruxelles, Brussels, Belgium.
Front Physiol. 2020 Dec 3;11:599896. doi: 10.3389/fphys.2020.599896. eCollection 2020.
INTRODUCTION: Auricular low-level transcutaneous vagus nerve stimulation (aLL-tVNS) has emerged as a promising technology for cardiac arrhythmia management but is still experimental. In this physiological study, we hypothesized that aLL-tVNS modulated the autonomic nervous balance through a reduction of sympathetic tone and an increase in heart rate variability (HRV). We investigated the muscle sympathetic nerve activity (MSNA) recorded by microneurography during vagally mediated aLL-tVNS and active control on healthy volunteers. METHODS: In this crossover, double-blind controlled study, healthy men ( = 28; 27 ± 4 years old) were assigned to aLL-tVNS applied to cymba and lobe (active control) of the right ear. Each participant was randomly allocated to the three sequences (5 Hz, 20 Hz, and active control-5 Hz) during one session. MSNA signal was recorded at rest, during voluntarily apnea and aLL-tVNS. Sympathetic activity was expressed as: 1) number of bursts per minute (burst frequency, BF) and 2) MSNA activity calculated as BF x mean burst amplitude and expressed as changes from baseline (%). RR intervals, HRV parameters and sympathetic activity were analyzed during 5 min-baseline, 10 min-stimulation, and 10 min-recovery periods. Mixed regression models were performed to evaluate cymba-(5-20 Hz) effects on the parameters with stimulation. RESULTS: During apnea and compared to baseline, BF and MSNA activity increased ( = 0.002, = 0.001, respectively). No stimulation effect on RR intervals and HRV parameters were showed excepted a slightly increase of the LF/HF ratio with stimulation in the cymba-5Hz sequence (coef. ± SE: 0.76 ± 0.32%; = 0.02). During stimulation, reductions from baseline in BF (Coef. ± SE: -4.8 ± 1.1, < 0.001) was observed but was not statistically different from that one in the active control. Reduction of MSNA activity was not significantly different between sequences. CONCLUSION: Acute right cymba aLL-tVNS did not induce any overall effects neither on heart rate, HRV nor MSNA variables on healthy subjects when compared to active control. Interestingly, these findings questioned the role of active controls in medical device clinical trials that implied subjective endpoints.
引言：耳郭低强度经皮迷走神经刺激（aLL-tVNS）已成为一种用于心律失常管理的有前景的技术，但仍处于实验阶段。在这项生理学研究中，我们假设aLL-tVNS通过降低交感神经张力和增加心率变异性（HRV）来调节自主神经平衡。我们研究了在健康志愿者进行迷走神经介导的aLL-tVNS和主动对照期间，通过微神经ography记录的肌肉交感神经活动（MSNA）。 方法：在这项交叉、双盲对照研究中，健康男性（n = 28；27±4岁）被分配接受应用于右耳舟状窝和耳垂（主动对照）的aLL-tVNS。在一次实验中，每个参与者被随机分配到三个序列（5Hz、20Hz和主动对照-5Hz）。在静息、自愿屏气和aLL-tVNS期间记录MSNA信号。交感神经活动表示为：1）每分钟爆发次数（爆发频率，BF）和2）以BF×平均爆发幅度计算并表示为相对于基线变化（%）的MSNA活动。在5分钟基线、10分钟刺激和10分钟恢复期分析RR间期、HRV参数和交感神经活动。进行混合回归模型以评估耳舟状窝-（5 - 20Hz）对刺激参数的影响。 结果：在屏气期间与基线相比，BF和MSNA活动增加（分别为P = 0.002，P = 0.001）。除了在耳舟状窝-5Hz序列中刺激时LF/HF比值略有增加外（系数±标准误：0.76±0.32%；P = 0.02），未显示对RR间期和HRV参数有刺激作用。在刺激期间，观察到BF相对于基线降低（系数±标准误：-4.8±1.1，P < 0.001），但与主动对照中的降低无统计学差异。序列间MSNA活动的降低无显著差异。 结论：与主动对照相比，急性右耳舟状窝aLL-tVNS对健康受试者的心率、HRV或MSNA变量均未产生任何总体影响。有趣的是，这些发现质疑了主动对照在涉及主观终点的医疗器械临床试验中的作用。
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