Non-invasive Vagus Nerve Stimulation for COVID-19: Results From a Randomized Controlled Trial (SAVIOR I).

COVID-19 biomarkers coronavirus inflammation neuromodulation non-invasive vagus nerve stimulation randomized control trial respiratory symptoms

Journal

Frontiers in neurology
ISSN: 1664-2295
Titre abrégé: Front Neurol
Pays: Switzerland
ID NLM: 101546899

Informations de publication

Date de publication:
2022
Historique:
received: 07 01 2022
accepted: 14 03 2022
entrez: 25 4 2022
pubmed: 26 4 2022
medline: 26 4 2022
Statut: epublish

Résumé

Severe coronavirus disease 2019 (COVID-19) is characterized, in part, by an excessive inflammatory response. Evidence from animal and human studies suggests that vagus nerve stimulation can lead to reduced levels of various biomarkers of inflammation. We conducted a prospective randomized controlled study (SAVIOR-I) to assess the feasibility, efficacy, and safety of non-invasive vagus nerve stimulation (nVNS) for the treatment of respiratory symptoms and inflammatory markers among patients who were hospitalized for COVID-19 (ClinicalTrials.gov identifier: NCT04368156). Participants were randomly assigned in a 1:1 allocation to receive either the standard of care (SoC) alone or nVNS therapy plus the SoC. The nVNS group received 2 consecutive 2-min doses of nVNS 3 times daily as prophylaxis. Efficacy and safety were evaluated Of the 110 participants who were enrolled and randomly assigned, 97 (nVNS, nVNS therapy led to significant reductions in levels of inflammatory markers, specifically CRP and procalcitonin. Because nVNS has multiple mechanisms of action that may be relevant to COVID-19, additional research into its potential use earlier in the course of COVID-19 and its potential to mitigate some of the symptoms associated with post-acute sequelae of COVID-19 is warranted.

Sections du résumé

Background UNASSIGNED
Severe coronavirus disease 2019 (COVID-19) is characterized, in part, by an excessive inflammatory response. Evidence from animal and human studies suggests that vagus nerve stimulation can lead to reduced levels of various biomarkers of inflammation. We conducted a prospective randomized controlled study (SAVIOR-I) to assess the feasibility, efficacy, and safety of non-invasive vagus nerve stimulation (nVNS) for the treatment of respiratory symptoms and inflammatory markers among patients who were hospitalized for COVID-19 (ClinicalTrials.gov identifier: NCT04368156).
Methods UNASSIGNED
Participants were randomly assigned in a 1:1 allocation to receive either the standard of care (SoC) alone or nVNS therapy plus the SoC. The nVNS group received 2 consecutive 2-min doses of nVNS 3 times daily as prophylaxis. Efficacy and safety were evaluated
Results UNASSIGNED
Of the 110 participants who were enrolled and randomly assigned, 97 (nVNS,
Conclusions UNASSIGNED
nVNS therapy led to significant reductions in levels of inflammatory markers, specifically CRP and procalcitonin. Because nVNS has multiple mechanisms of action that may be relevant to COVID-19, additional research into its potential use earlier in the course of COVID-19 and its potential to mitigate some of the symptoms associated with post-acute sequelae of COVID-19 is warranted.

Identifiants

pubmed: 35463130
doi: 10.3389/fneur.2022.820864
pmc: PMC9028764
doi:

Banques de données

ClinicalTrials.gov
['NCT04368156']

Types de publication

Journal Article

Langues

eng

Pagination

820864

Informations de copyright

Copyright © 2022 Tornero, Pastor, Garzando, Orduña, Forner, Bocigas, Cedeño, Vallejo, McClure, Czura, Liebler and Staats.

Déclaration de conflit d'intérêts

DC has served as a consultant and advisory board member for Medtronic, Inc. RV is director of research for the National Spine and Pain Centers, a consultant and advisory board member for Medtronic, Inc., and chief executive officer for SGX Medical, LLC. CM is an employee of NAMSA, Inc., CC is a consultant for electroCore, Inc. and an employee of Convergent Medical Technologies, Inc., EL is an employee of electroCore, Inc., and receives stock ownership. PS is an employee and was cofounder of electroCore, Inc., and receives stock ownership. Author CC was employed by company Convergent Medical Technologies, Inc. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Références

JAMA. 2020 Apr 7;323(13):1239-1242
pubmed: 32091533
Brain Behav. 2021 Jun;11(6):e02185
pubmed: 33998177
Cephalalgia. 2017 Nov;37(13):1285-1293
pubmed: 28648089
Front Neurosci. 2021 Apr 13;15:667036
pubmed: 33927594
Blood Res. 2021 Jun 30;56(2):61-64
pubmed: 34083499
Cephalalgia. 2020 Oct;40(12):1370-1384
pubmed: 32718243
Proc Natl Acad Sci U S A. 2016 Jul 19;113(29):8284-9
pubmed: 27382171
Ann Acad Med Singap. 2020 Jan;49(3):108-118
pubmed: 32200400
Front Neurosci. 2021 Mar 22;15:650971
pubmed: 33828455
Blood. 2020 Jul 23;136(4):489-500
pubmed: 32492712
Brain Behav Immun. 2019 Oct;81:444-454
pubmed: 31271871
JACC Clin Electrophysiol. 2017 Sep;3(9):929-938
pubmed: 29759717
Shock. 2008 Oct;30(4):468-72
pubmed: 18391858
Neuromodulation. 2019 Jul;22(5):580-585
pubmed: 30328647
Mol Med. 2020 Jun 29;26(1):64
pubmed: 32600316
Int J Med Sci. 2020 Sep 9;17(16):2468-2476
pubmed: 33029089
Cell Rep Med. 2020 Nov 17;1(8):100144
pubmed: 33163981
Mol Med Rep. 2016 May;13(5):4122-8
pubmed: 27035526
PLoS One. 2020 Sep 18;15(9):e0239174
pubmed: 32946466
Front Physiol. 2020 Jul 28;11:890
pubmed: 32848845
J Med Virol. 2020 Jul;92(7):856-862
pubmed: 32281668
NPJ Parkinsons Dis. 2021 May 27;7(1):46
pubmed: 34045464
JAMA. 2020 Oct 6;324(13):1307-1316
pubmed: 32876695
Front Neurol. 2020 Nov 25;11:573718
pubmed: 33324324
Frontline Gastroenterol. 2017 Oct;8(4):325-330
pubmed: 29067158
Eur Heart J. 2021 Jun 14;42(23):2270-2279
pubmed: 33448289
Brain Behav Immun Health. 2020 Sep 11;9:100138
pubmed: 34589887
Int J Antimicrob Agents. 2020 Aug;56(2):106051
pubmed: 32534186
Med Hypotheses. 2020 Oct;143:110093
pubmed: 33017913
Front Med (Lausanne). 2021 May 07;8:625836
pubmed: 34026778
Colorectal Dis. 2021 May;23(5):1225-1232
pubmed: 33539637
Front Immunol. 2021 Feb 08;11:595342
pubmed: 33633726
Eur Respir J. 2020 Apr 23;55(4):
pubmed: 32269090
Crit Care Med. 2019 Jun;47(6):e461-e469
pubmed: 30908312
J Cutan Med Surg. 2021 Nov-Dec;25(6):627-633
pubmed: 33849305
Int J Epidemiol. 2021 May 17;50(2):420-429
pubmed: 33683344
Nature. 2002 Dec 19-26;420(6917):853-9
pubmed: 12490958
Annu Rev Immunol. 2018 Apr 26;36:783-812
pubmed: 29677475
J Cardiovasc Transl Res. 2020 Dec;13(6):894-899
pubmed: 32458400
Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620937175
pubmed: 32615866
Nature. 2003 Jan 23;421(6921):384-8
pubmed: 12508119
Crit Care Med. 2007 Dec;35(12):2762-8
pubmed: 17901837
Neuromodulation. 2020 Aug;23(6):784-788
pubmed: 32342609
N Engl J Med. 2021 Apr 22;384(16):1572-1573
pubmed: 33882210

Auteurs

Carlos Tornero (C)

Hospital Clínico Universitario de Valencia, Anesthesia, Critical Care and Pain Management Unit, Valencia, Spain.
Cátedra Dolor, UFV-Fundación Vithas, Madrid, Spain.

Ernesto Pastor (E)

Hospital Clínico Universitario de Valencia, Anesthesia, Critical Care and Pain Management Unit, Valencia, Spain.

María Del Mar Garzando (MDM)

Hospital Clínico Universitario de Valencia, Anesthesia, Critical Care and Pain Management Unit, Valencia, Spain.

Jorge Orduña (J)

Hospital Clínico Universitario de Valencia, Anesthesia, Critical Care and Pain Management Unit, Valencia, Spain.

Maria J Forner (MJ)

Hospital Clínico Universitario de Valencia, Internal Medicine Department, Valencia, Spain.

Irene Bocigas (I)

Hospital Clínico Universitario de Valencia, Pulmonary Department, Valencia, Spain.

David L Cedeño (DL)

Department of Basic Science, Millennium Pain Center, Bloomington, IL, United States.
Department of Psychology, Illinois Wesleyan University, Bloomington, IL, United States.

Ricardo Vallejo (R)

Department of Basic Science, Millennium Pain Center, Bloomington, IL, United States.
Department of Psychology, Illinois Wesleyan University, Bloomington, IL, United States.

Candace K McClure (CK)

NAMSA, Minneapolis, MN, United States.

Christopher J Czura (CJ)

Convergent Medical Technologies, Inc., Oyster Bay, NY, United States.

Eric J Liebler (EJ)

electroCore, Inc., Rockaway, NJ, United States.

Peter Staats (P)

electroCore, Inc., Rockaway, NJ, United States.

Classifications MeSH