Federal University of Paraíba, João Pessoa, Brazil.
Federal University of Paraíba, João Pessoa, Brazil.
Brain Stimul. 2022 May-Jun;15(3):780-788. doi: 10.1016/j.brs.2022.05.006. Epub 2022 May 11.
Acute Respiratory Distress Syndrome (ADRS) due to coronavirus disease 2019 (COVID-19) has been associated with muscle fatigue, corticospinal pathways dysfunction, and mortality. High-Definition transcranial Direct Current Stimulation (HD-tDCS) may be used to attenuate clinical impairment in these patients. The HD-RECOVERY randomized clinical trial was conducted to evaluate the efficacy and safety of HD-tDCS with respiratory rehabilitation in patients with moderate to severe ARDS due to COVID-19.
Fifty-six critically ill patients were randomized 1:1 to active (n = 28) or sham (n = 28) HD-tDCS (twice a day, 30-min, 3-mA) plus respiratory rehabilitation for up to 10 days or until intensive care unit discharge. The primary outcome was ventilator-free days during the first 28 days, defined as the number of days free from mechanical ventilation. Furthermore, secondary outcomes such as delirium, organ failure, hospital length of stay and adverse effects were investigated.
Active HD-tDCS induced more ventilator-free days compared to sham HD-tDCS. Patients in the active group vs in the sham group experienced lower organ dysfunction, delirium, and length of stay rates over time. In addition, positive clinical response was higher in the active vs sham group. There was no significant difference in the prespecified secondary outcomes at 5 days. Adverse events were similar between groups.
Among patients with COVID-19 and moderate to severe ARDS, use of active HD-tDCS compared with sham HD-tDCS plus respiratory rehabilitation resulted in a statistically significant increase in the number of ventilator-free days over 28 days. HD-tDCS combined with concurrent rehabilitation therapy is a safe, feasible, potentially add-on intervention, and further trials should examine HD-tDCS efficacy in a larger sample of patients with COVID-19 and severe hypoxemia.
由 2019 年冠状病毒病（COVID-19）引起的急性呼吸窘迫综合征（ARDS）与肌肉疲劳、皮质脊髓通路功能障碍和死亡率有关。高清晰度经颅直流电刺激（HD-tDCS）可用于减轻这些患者的临床损伤。HD-RECOVERY 随机临床试验旨在评估 HD-tDCS 联合呼吸康复治疗 COVID-19 中度至重度 ARDS 患者的疗效和安全性。
将 56 例危重症患者随机分为 1:1 接受主动（n=28）或假（n=28）HD-tDCS（每天 2 次，30 分钟，3 mA）联合呼吸康复治疗，最长 10 天或直至重症监护病房出院。主要结局为第 1 至 28 天期间的无呼吸机天数，定义为无机械通气天数。此外，还研究了谵妄、器官衰竭、住院时间和不良事件等次要结局。
与假 HD-tDCS 相比，主动 HD-tDCS 诱导的无呼吸机天数更多。主动组患者的器官功能障碍、谵妄和住院时间率低于假组。此外，主动组的临床反应阳性率更高。在第 5 天，预设的次要结局没有显著差异。两组不良事件相似。
在 COVID-19 合并中度至重度 ARDS 的患者中，与假 HD-tDCS 联合呼吸康复相比，使用主动 HD-tDCS 可使 28 天内的无呼吸机天数显著增加。HD-tDCS 联合同时进行的康复治疗是一种安全、可行的潜在附加干预措施，进一步的试验应在更大的 COVID-19 和严重低氧血症患者样本中检验 HD-tDCS 的疗效。
