Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol

Eric Azabou; Guillaume Bao; Nicholas Heming; Rania Bounab; Pierre Moine; Sylvain Chevallier; Sylvie Chevret; Matthieu Resche-Rigon; Shidaps Siami; Tarek Sharshar; Frederic Lofaso; Djillali Annane

doi:10.3389/fmed.2020.00372

Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol

Front Med (Lausanne). 2020 Jun 26:7:372. doi: 10.3389/fmed.2020.00372. eCollection 2020.

Authors

Eric Azabou¹, Guillaume Bao¹, Nicholas Heming², Rania Bounab², Pierre Moine², Sylvain Chevallier³, Sylvie Chevret^{4

5

6}, Matthieu Resche-Rigon^{4

5

6}, Shidaps Siami⁷, Tarek Sharshar^{8

9}, Frederic Lofaso¹, Djillali Annane²

Affiliations

¹ Clinical Neurophysiology and Neuromodulation Unit, Departments of Physiology and Critical Care Medicine, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.
² General Intensive Care Unit-Assistance Publique Hôpitaux de Paris, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.
³ Versailles Engineering Systems Laboratory (LISV), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Velizy, France.
⁴ Service de Biostatistique et Information Médicale, AP-HP Hôpital Saint Louis, Paris, France.
⁵ Inserm U1153 CRESS, Epidemiology and Clinical Statistics for Tumor, Respiratory, and Resuscitation Assessments (ECSTRRA) Team, Paris, France.
⁶ Université Paris 7 Diderot, Sorbonne Paris Cité, Paris, France.
⁷ Critical Care Medicine Unit, CH Etampes-Dourdan, Etampes, France.
⁸ Department of Neuro-Intensive Care Medicine, Sainte-Anne Hospital, Paris-Descartes University, Paris, France.
⁹ Laboratory of Human Histopathology and Animal Models, Institut Pasteur, Paris, France.

Abstract

The severe respiratory distress syndrome linked to the new coronavirus disease (COVID-19) includes unbearable dyspneic suffering which contributes to the deterioration of the prognosis of patients in intensive care unit (ICU). Patients are put on mechanical ventilation to reduce respiratory suffering and preserve life. Despite this mechanical ventilation, most patients continue to suffer from dyspnea. Dyspnea is a major source of suffering in intensive care and one of the main factors that affect the prognosis of patients. The development of innovative methods for its management, especially non-drug management is more than necessary. In recent years, numerous studies have shown that transcranial direct current stimulation (tDCS) could modulate the perception of acute or chronic pain. In the other hand, it has been shown that the brain zones activated during pain and dyspnea are close and/or superimposed, suggesting that brain structures involved in the integration of aversive emotional component are shared by these two complex sensory experiences. Therefore, it can be hypothesized that stimulation by tDCS with regard to the areas which, in the case of pain have activated one or more of these brain structures, may also have an effect on dyspnea. In addition, our team recently demonstrated that the application of tDCS on the primary cortical motor area can modulate the excitability of the respiratory neurological pathways. Indeed, tDCS in anodal or cathodal modality reduced the excitability of the diaphragmatic cortico-spinal pathways in healthy subjects. We therefore hypothesized that tDCS could relieve dyspnea in COVID-19 patients under mechanical ventilation in ICU. This study was designed to evaluate effects of two modalities of tDCS (anodal and cathodal) vs. placebo, on the relief of dyspnea in COVID-19 patients requiring mechanical ventilation in ICU. Trial Registration: This protocol is derived from the tDCS-DYSP-REA project registered on ClinicalTrials.gov NCT03640455. It will however be registered under its own NCT number.

Keywords: COVID-19; ICU; acute respiratory distress syndrome (ARDS); brain; dyspnea relief; mechanical ventilation; neuromodulation; tDCS.

Associated data

ClinicalTrials.gov/NCT03640455