TY - JOUR
T1 - Efficacy and safety of HD-tDCS and respiratory rehabilitation for critically ill patients with COVID-19 The HD-RECOVERY randomized clinical trial
AU - Andrade, Suellen Marinho
AU - Cecília de Araújo Silvestre, Maria
AU - Tenório de França, Eduardo Ériko
AU - Bezerra Sales Queiroz, Maria Heloísa
AU - de Jesus Santana, Kelly
AU - Lima Holmes Madruga, Marcela Lais
AU - Torres Teixeira Mendes, Cristina Katya
AU - Araújo de Oliveira, Eliane
AU - Bezerra, João Felipe
AU - Barreto, Renata Gomes
AU - Alves Fernandes da Silva, Silmara Maria
AU - Alves de Sousa, Thais
AU - Medeiros de Sousa, Wendy Chrystyan
AU - Patrícia da Silva, Mariana
AU - Cintra Ribeiro, Vanessa Meira
AU - Lucena, Paulo
AU - Beltrammi, Daniel
AU - Catharino, Rodrigo Ramos
AU - Caparelli-Dáquer, Egas
AU - Hampstead, Benjamin M.
AU - Datta, Abhishek
AU - Teixeira, Antonio Lucio
AU - Fernández-Calvo, Bernardino
AU - Sato, João Ricardo
AU - Bikson, Marom
N1 - Publisher Copyright:
© 2022
PY - 2022/5/1
Y1 - 2022/5/1
N2 - Background and purpose: 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. 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.
AB - Background and purpose: 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. 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.
KW - Acute respiratory distress syndrome
KW - Coronavirus disease
KW - High-definition transcranial direct current stimulation
KW - Noninvasive brain stimulation
KW - Respiratory rehabilitation
UR - https://www.scopus.com/pages/publications/85130512963
UR - https://www.scopus.com/inward/citedby.url?scp=85130512963&partnerID=8YFLogxK
U2 - 10.1016/j.brs.2022.05.006
DO - 10.1016/j.brs.2022.05.006
M3 - Article
C2 - 35568312
AN - SCOPUS:85130512963
SN - 1935-861X
VL - 15
SP - 780
EP - 788
JO - Brain Stimulation
JF - Brain Stimulation
IS - 3
ER -