PDF(Pubmed)
Abstract：
BACKGROUND: The autonomic nervous system plays a vital role in regulating physiological functions. Transcutaneous auricular vagus nerve stimulation (taVNS) is a method that provides insights into autonomic nerve modulation. This paper presents a research protocol investigating proof of mechanism for the impact of taVNS on autonomic functions and aims to both deepen theoretical understanding and pave the way for clinically relevant applications.
METHODS: This protocol employs a single-blind, randomized cross-over design involving 10 healthy male participants. Simultaneous assessment of both the afferent and efferent aspects of the vagus nerve will be performed by integrating physiological measures, magnetic resonance imaging, and a questionnaire survey. Electrocardiogram will be measured to assess changes in heart rate, as a primary outcome, and heart rate variability. Active taVNS and sham stimulation will be compared, which ensures precision and blinding. Electrical stimulation will be applied to the left concha cymba and the left lobule for the active and sham conditions, respectively. The specific parameters of taVNS involve a pulse width of 250 µs, a frequency of 25 Hz, and a current adjusted to the perception threshold (0.1 mA ≤ 5 mA), delivered in cycles of 32 s on and 28 s off.
CONCLUSIONS: This research investigates proof of mechanism for taVNS to elucidate its modulatory effects on the central and peripheral components of the autonomic nervous system. Beyond theoretical insights, the findings will provide a foundation for designing targeted neuromodulation strategies, potentially benefiting diverse patient populations experiencing autonomic dysregulation. By elucidating the neural mechanisms, this study contributes to the evolution of personalized and effective clinical interventions in the field of neuromodulation.
BACKGROUND: JRCT, jRCTs032220332, Registered 13 September 2022; https://jrct.niph.go.jp/latest-detail/jRCTs032220332 .
METHODS: This protocol employs a single-blind, randomized cross-over design involving 10 healthy male participants. Simultaneous assessment of both the afferent and efferent aspects of the vagus nerve will be performed by integrating physiological measures, magnetic resonance imaging, and a questionnaire survey. Electrocardiogram will be measured to assess changes in heart rate, as a primary outcome, and heart rate variability. Active taVNS and sham stimulation will be compared, which ensures precision and blinding. Electrical stimulation will be applied to the left concha cymba and the left lobule for the active and sham conditions, respectively. The specific parameters of taVNS involve a pulse width of 250 µs, a frequency of 25 Hz, and a current adjusted to the perception threshold (0.1 mA ≤ 5 mA), delivered in cycles of 32 s on and 28 s off.
CONCLUSIONS: This research investigates proof of mechanism for taVNS to elucidate its modulatory effects on the central and peripheral components of the autonomic nervous system. Beyond theoretical insights, the findings will provide a foundation for designing targeted neuromodulation strategies, potentially benefiting diverse patient populations experiencing autonomic dysregulation. By elucidating the neural mechanisms, this study contributes to the evolution of personalized and effective clinical interventions in the field of neuromodulation.
BACKGROUND: JRCT, jRCTs032220332, Registered 13 September 2022; https://jrct.niph.go.jp/latest-detail/jRCTs032220332 .
摘要：
背景：自主神经系统在调节生理功能中起着至关重要的作用。经皮耳迷走神经刺激（taVNS）是一种提供对自主神经调节的见解的方法。本文提出了一项研究协议，研究了taVNS对自主功能影响的机制证明，旨在加深理论理解并为临床相关应用铺平道路。
方法：此协议采用单盲，随机交叉设计，包括10名健康男性参与者。通过整合生理措施，同时评估迷走神经的传入和传出方面。磁共振成像，和问卷调查。将测量心电图以评估心率的变化，作为主要结果，和心率变异性。将比较活性taVNS和假刺激，这确保了精度和盲法。对于活动和假性条件，将对左cymba和左小叶施加电刺激。分别。taVNS的特定参数涉及250µs的脉冲宽度，频率为25Hz,和电流调整到感知阈值（0.1mA≤5mA），在32秒和28秒的周期内交付。
结论：这项研究调查了taVNS机制的证据，以阐明其对自主神经系统中枢和外周成分的调节作用。除了理论见解之外，这些发现将为设计有针对性的神经调节策略奠定基础，可能有利于经历自主神经失调的不同患者人群。通过阐明神经机制，这项研究有助于神经调节领域个性化和有效的临床干预措施的发展。
背景：JRCT，jRCTs032220332，2022年9月13日注册；https://jrct。尼夫.走吧。jp/latest-detail/jRCTs032220332.
方法：此协议采用单盲，随机交叉设计，包括10名健康男性参与者。通过整合生理措施，同时评估迷走神经的传入和传出方面。磁共振成像，和问卷调查。将测量心电图以评估心率的变化，作为主要结果，和心率变异性。将比较活性taVNS和假刺激，这确保了精度和盲法。对于活动和假性条件，将对左cymba和左小叶施加电刺激。分别。taVNS的特定参数涉及250µs的脉冲宽度，频率为25Hz,和电流调整到感知阈值（0.1mA≤5mA），在32秒和28秒的周期内交付。
结论：这项研究调查了taVNS机制的证据，以阐明其对自主神经系统中枢和外周成分的调节作用。除了理论见解之外，这些发现将为设计有针对性的神经调节策略奠定基础，可能有利于经历自主神经失调的不同患者人群。通过阐明神经机制，这项研究有助于神经调节领域个性化和有效的临床干预措施的发展。
背景：JRCT，jRCTs032220332，2022年9月13日注册；https://jrct。尼夫.走吧。jp/latest-detail/jRCTs032220332.
