Efficacy and safety of HD-tDCS and respiratory rehabilitation for critically ill patients with COVID-19 The HD-RECOVERY randomized clinical trial.
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Andrade Suellen Marinho, Cecília de Araújo Silvestre Maria, Tenório de França Eduardo Ériko, Bezerra Sales Queiroz Maria Heloísa, de Jesus Santana Kelly, Lima Holmes Madruga Marcela Lais, Torres Teixeira Mendes Cristina Katya, Araújo de Oliveira Eliane, Bezerra João Felipe, Barreto Renata Gomes, Alves Fernandes da Silva Silmara Maria, Alves de Sousa Thais, Medeiros de Sousa Wendy Chrystyan, Patrícia da Silva Mariana, Cintra Ribeiro Vanessa Meira, Lucena Paulo, Beltrammi Daniel, Catharino Rodrigo Ramos, Caparelli-Dáquer Egas, Hampstead Benjamin M, Datta Abhishek, Teixeira Antonio Lucio, Fernández-Calvo Bernardino, Sato João Ricardo, Bikson Marom
Аннотация
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.