Rehabilitation Sciences, Nove de Julho University, São Paulo, Brazil.
Harvard Medical School, Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Boston, Mass, USA.
Expert Rev Med Devices. 2022 Nov;19(11):915-920. doi: 10.1080/17434440.2022.2154147.
To evaluate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on inflammatory markers and clinical outcomes in patients with COVID-19.
A randomized blinded pilot study was carried out with 21 individuals hospitalized with COVID-19 who received 14 sessions of active (a-taVNS) or sham taVNS (s-taVNS). The level of interleukin-6 (IL-6), interleukin-10 (IL-10), cortisol, and C-reactive protein (CRP) in plasma and clinical evolution pre- and post-intervention were evaluated. The memory and attention levels were evaluated 14 days after the end of the treatment.
After treatment, significant intragroup differences were found in the CRP (p = 0.01), IL-6 (p = 0.01), and cortisol (p = 0.01) levels; however, in the comparison between the groups, only the CRP level was statistically lower for the a-taVNS (p = 0.04). The impression of improvement in memory and attention was greater in the a-taVNS than in the s-taVNS (p = 0.01, p = 0.04, respectively). There was no difference between the other clinical outcomes.
taVNS is a viable and safe intervention in the acute care of patients with COVID-19, which can modulate their inflammatory profile and improve cognitive symptoms. However, improvements in overall clinical outcomes were not detected. Larger sample sizes and longer follow-ups are needed to confirm the anti-inflammatory and clinical effects of taVNS in patients with COVID-19.
The Brazilian Registry of Clinical Trials (RBR-399t4g5).
评估经皮耳迷走神经刺激（taVNS）对 COVID-19 患者炎症标志物和临床结局的影响。
对 21 名住院 COVID-19 患者进行了一项随机、双盲的初步研究，这些患者接受了 14 次主动（a-taVNS）或假 taVNS（s-taVNS）治疗。评估了干预前后血浆中白细胞介素-6（IL-6）、白细胞介素-10（IL-10）、皮质醇和 C 反应蛋白（CRP）的水平以及临床演变。在治疗结束后 14 天评估了记忆和注意力水平。
治疗后，CRP（p=0.01）、IL-6（p=0.01）和皮质醇（p=0.01）水平的组内差异具有统计学意义；然而，在组间比较中，只有 a-taVNS 组的 CRP 水平具有统计学意义（p=0.04）。a-taVNS 组的记忆和注意力改善印象明显大于 s-taVNS 组（p=0.01，p=0.04）。其他临床结局无差异。
taVNS 是 COVID-19 患者急性治疗的一种可行且安全的干预措施，可调节其炎症谱并改善认知症状。然而，并未检测到总体临床结局的改善。需要更大的样本量和更长的随访时间来确认 taVNS 在 COVID-19 患者中的抗炎和临床效果。
巴西临床试验注册处（RBR-399t4g5）。
