经皮耳迷走神经刺激对COVID-19患者炎症、心脏自主神经调节和临床演变的影响:临床、对照、随机、盲试验方案

Laura Uehara, J. C. Corrêa, P. Leite, R. Ritti-Dias, F. Fregni, F. I. Corrêa
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引用次数: 0

摘要

本研究旨在评估经皮耳迷走神经刺激(taVNS)对COVID-19患者炎症、心脏自主神经调节和临床演变的影响。这是一项临床、假对照、随机和盲试验,将有52名被诊断为COVID-19的住院患者参加。他们将随机分为:实验组(与活动性taVNS相关的常规药物治疗)和对照组(与假性taVNS相关的常规药物治疗)。taVNS将通过神经肌肉电刺激器(夸克医疗产品的Dualpex型号071)进行,刺激电极位于左耳屏上,频率为30Hz,变化为50%。强度将根据患者的感觉阈值进行调整,每次90分钟的刺激疗程,每天进行两次,连续7天,共计14次。评估干预前后的白细胞介素-6 (IL-6)、白细胞介素-10 (IL-10)、皮质醇、c反应蛋白(CRP)、血压、低频(LF)、高频(HF)、低、高频比(LF/HF)参数的心率变异性(HRV),以及患者的临床演变,包括焦虑、抑郁水平,通过病历和问卷获取数据。干预结束后7天和14天还将进行随访,以验证临床进展,包括焦虑和抑郁水平。记忆力和注意力水平将被评估六个月。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effects of transcutaneous auricular vagus nerve stimulation on inflammation, cardiac autonomic modulation, and clinical evolution of patients with COVID-19: protocol for a clinical, controlled, randomized, and blind trial
ABSTRACT This study aims to evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) on inflammation, cardiac autonomic modulation, and clinical evolution of patients with COVID-19. This is a clinical, sham-controlled, randomized, and blind trial, in which 52 hospitalized individuals diagnosed with COVID-19 will participate. They will be randomized into: experimental group (usual medical treatment associated with active taVNS) and control group (usual medical treatment associated with sham taVNS). The taVNS will be performed by a neuromuscular electric stimulator (Dualpex model 071 of Quark Medical Products), with the stimulation electrode positioned on the left tragus, with alternating current, at a 30Hz frequency with 50% variation. Intensity will be adjusted to the patient’s sensory threshold, with 90-minutes-long stimulation sessions, happening twice per day for seven consecutive days, totaling 14 sessions. Interleukin-6 (IL-6) and interleukin-10 (IL-10), cortisol and C-reactive protein (CRP), blood pressure, heart rate variability (HRV) by low frequency (LF), high frequency (HF) and low and high frequency ratio (LF/HF) parameters will be evaluated before and after the intervention, as well as patients’ clinical evolution-including anxiety and depression levels-whose data will be obtained through medical records and questionnaires. A follow-up will also be performed seven and 14 days after the end of the interventions to verify the clinical evolution, including anxiety and depression levels. Memory and attention levels will be evaluated for six months.
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