Brain Stimulation (May 2022)

Efficacy and safety of HD-tDCS and respiratory rehabilitation for critically ill patients with COVID-19 The HD-RECOVERY randomized clinical trial

  • Suellen Marinho Andrade,
  • Maria Cecília de Araújo Silvestre,
  • Eduardo Ériko Tenório de França,
  • Maria Heloísa Bezerra Sales Queiroz,
  • Kelly de Jesus Santana,
  • Marcela Lais Lima Holmes Madruga,
  • Cristina Katya Torres Teixeira Mendes,
  • Eliane Araújo de Oliveira,
  • João Felipe Bezerra,
  • Renata Gomes Barreto,
  • Silmara Maria Alves Fernandes da Silva,
  • Thais Alves de Sousa,
  • Wendy Chrystyan Medeiros de Sousa,
  • Mariana Patrícia da Silva,
  • Vanessa Meira Cintra Ribeiro,
  • Paulo Lucena,
  • Daniel Beltrammi,
  • Rodrigo Ramos Catharino,
  • Egas Caparelli-Dáquer,
  • Benjamin M. Hampstead,
  • Abhishek Datta,
  • Antonio Lucio Teixeira,
  • Bernardino Fernández-Calvo,
  • João Ricardo Sato,
  • Marom Bikson

Journal volume & issue
Vol. 15, no. 3
pp. 780 – 788

Abstract

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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.

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