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

Brain Stimulation

卷:15

Maria Cecília de Araújo Silvestre¹  Antonio Lucio Teixeira²  Bernardino Fernández-Calvo³  João Ricardo Sato⁴  Marom Bikson⁵  Eduardo Ériko Tenório de França⁶  Vanessa Meira Cintra Ribeiro⁶  Silmara Maria Alves Fernandes da Silva⁶  Renata Gomes Barreto⁶  Cristina Katya Torres Teixeira Mendes⁶  João Felipe Bezerra⁶  Marcela Lais Lima Holmes Madruga⁶  Mariana Patrícia da Silva⁶  Eliane Araújo de Oliveira⁶  Kelly de Jesus Santana⁶  Wendy Chrystyan Medeiros de Sousa⁶  Thais Alves de Sousa⁶  Suellen Marinho Andrade⁶  Paulo Lucena⁷  Daniel Beltrammi⁷  Maria Heloísa Bezerra Sales Queiroz⁷  Rodrigo Ramos Catharino⁷  Benjamin M. Hampstead⁸  Abhishek Datta⁹  Egas Caparelli-Dáquer¹⁰ 

[1] Corresponding author. Health Center, Neuroscience and Aging Laboratory, Campus I, 58051-085, Paraíba, Brazil.;

[2] Mental Health Service, VA Ann Arbor Healthcare System, Ann Arbor, Ann Arbor, United States;

[3] Department of Biomedical Engineering, The City College of New York of CUNY, New York, United States;

[4] Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center, Houston, United States;

[5] Department of Psychology, University of Cordoba, Cordoba, Spain;

[6] Federal University of Paraíba, João Pessoa, Brazil;

[7] Health Secretary, Government of Paraíba, João Pessoa, Brazil;

[8] Nervous System Electric Stimulation Lab, Rio de Janeiro State University, Rio de Janeiro, Brazil;

[9] Research Program on Cognition and Neuromodulation Based Interventions, Department of Psychiatry, University of Michigan &

[10] Thomson Mass Spectrometry Laboratory, Institute of Chemistry, State University of Campinas, UNICAMP, Campinas, SP, Brazil;

关键词: High-definition transcranial direct current stimulation;    Noninvasive brain stimulation;    Coronavirus disease;    Acute respiratory distress syndrome;    Respiratory rehabilitation;   

DOI  :  

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown