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

Autor: Andrade SM; Federal University of Paraíba, João Pessoa, Brazil. Electronic address: suellen.andrade@academico.ufpb.br., Cecília de Araújo Silvestre M; Federal University of Paraíba, João Pessoa, Brazil., Tenório de França EÉ; Health Secretary, Government of Paraíba, João Pessoa, Brazil., Bezerra Sales Queiroz MH; Federal University of Paraíba, João Pessoa, Brazil., de Jesus Santana K; Federal University of Paraíba, João Pessoa, Brazil., Lima Holmes Madruga ML; Federal University of Paraíba, João Pessoa, Brazil., Torres Teixeira Mendes CK; Federal University of Paraíba, João Pessoa, Brazil., Araújo de Oliveira E; Federal University of Paraíba, João Pessoa, Brazil., Bezerra JF; Federal University of Paraíba, João Pessoa, Brazil., Barreto RG; Federal University of Paraíba, João Pessoa, Brazil., Alves Fernandes da Silva SM; Federal University of Paraíba, João Pessoa, Brazil., Alves de Sousa T; Federal University of Paraíba, João Pessoa, Brazil., Medeiros de Sousa WC; Federal University of Paraíba, João Pessoa, Brazil., Patrícia da Silva M; Federal University of Paraíba, João Pessoa, Brazil., Cintra Ribeiro VM; Health Secretary, Government of Paraíba, João Pessoa, Brazil., Lucena P; Health Secretary, Government of Paraíba, João Pessoa, Brazil., Beltrammi D; Health Secretary, Government of Paraíba, João Pessoa, Brazil., Catharino RR; Thomson Mass Spectrometry Laboratory, Institute of Chemistry, State University of Campinas, UNICAMP, Campinas, SP, Brazil., Caparelli-Dáquer E; Nervous System Electric Stimulation Lab, Rio de Janeiro State University, Rio de Janeiro, Brazil., Hampstead BM; Research Program on Cognition and Neuromodulation Based Interventions, Department of Psychiatry, University of Michigan & Mental Health Service, VA Ann Arbor Healthcare System, Ann Arbor, Ann Arbor, United States., Datta A; Department of Biomedical Engineering, The City College of New York of CUNY, New York, United States., Teixeira AL; Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center, Houston, United States., Fernández-Calvo B; Department of Psychology, University of Cordoba, Cordoba, Spain; Maimonides Biomedical Research Institute of Cordoba (IMIBIC), University of Cordoba, Cordoba, Spain., Sato JR; Center of Mathematics, Computing and Cognition. Federal University of ABC, Santo André, Brazil., Bikson M; Department of Biomedical Engineering, The City College of New York of CUNY, New York, United States.
Jazyk: angličtina
Zdroj: Brain stimulation [Brain Stimul] 2022 May-Jun; Vol. 15 (3), pp. 780-788. Date of Electronic Publication: 2022 May 11.
DOI: 10.1016/j.brs.2022.05.006
Abstrakt: 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.
Competing Interests: Declaration of competing interest The City University of New York holds patents on brain stimulation with MB as inventor. MB has equity in Soterix Medical Inc. MB consults, received grants, assigned inventions, and/or serves on the SAB of SafeToddles, Boston Scientific, GlaxoSmithKline, Biophysics, Mecta, Lumenis, Halo Neuroscience, Google-X, i-Lumen, Humm, Allergan (Abbvie), Apple. AD is an employee and has equity in Soterix Medical Inc.
(Copyright © 2022. Published by Elsevier Inc.)
Databáze: MEDLINE
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