Cargando…

Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography

Introduction: Auricular low-level transcutaneous vagus nerve stimulation (aLL-tVNS) has emerged as a promising technology for cardiac arrhythmia management but is still experimental. In this physiological study, we hypothesized that aLL-tVNS modulated the autonomic nervous balance through a reductio...

Descripción completa

Detalles Bibliográficos
Autores principales: Gauthey, Anaïs, Morra, Sofia, van de Borne, Philippe, Deriaz, Denis, Maes, Nathalie, le Polain de Waroux, Jean-Benoît
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7744823/
https://www.ncbi.nlm.nih.gov/pubmed/33343394
http://dx.doi.org/10.3389/fphys.2020.599896
_version_ 1783624505950732288
author Gauthey, Anaïs
Morra, Sofia
van de Borne, Philippe
Deriaz, Denis
Maes, Nathalie
le Polain de Waroux, Jean-Benoît
author_facet Gauthey, Anaïs
Morra, Sofia
van de Borne, Philippe
Deriaz, Denis
Maes, Nathalie
le Polain de Waroux, Jean-Benoît
author_sort Gauthey, Anaïs
collection PubMed
description Introduction: Auricular low-level transcutaneous vagus nerve stimulation (aLL-tVNS) has emerged as a promising technology for cardiac arrhythmia management but is still experimental. In this physiological study, we hypothesized that aLL-tVNS modulated the autonomic nervous balance through a reduction of sympathetic tone and an increase in heart rate variability (HRV). We investigated the muscle sympathetic nerve activity (MSNA) recorded by microneurography during vagally mediated aLL-tVNS and active control on healthy volunteers. Methods: In this crossover, double-blind controlled study, healthy men (N = 28; 27 ± 4 years old) were assigned to aLL-tVNS applied to cymba and lobe (active control) of the right ear. Each participant was randomly allocated to the three sequences (5 Hz, 20 Hz, and active control-5 Hz) during one session. MSNA signal was recorded at rest, during voluntarily apnea and aLL-tVNS. Sympathetic activity was expressed as: 1) number of bursts per minute (burst frequency, BF) and 2) MSNA activity calculated as BF x mean burst amplitude and expressed as changes from baseline (%). RR intervals, HRV parameters and sympathetic activity were analyzed during 5 min-baseline, 10 min-stimulation, and 10 min-recovery periods. Mixed regression models were performed to evaluate cymba-(5—20 Hz) effects on the parameters with stimulation. Results: During apnea and compared to baseline, BF and MSNA activity increased (p = 0.002, p = 0.001, respectively). No stimulation effect on RR intervals and HRV parameters were showed excepted a slightly increase of the LF/HF ratio with stimulation in the cymba-5Hz sequence (coef. ± SE: 0.76 ± 0.32%; p = 0.02). During stimulation, reductions from baseline in BF (Coef. ± SE: −4.8 ± 1.1, p < 0.001) was observed but was not statistically different from that one in the active control. Reduction of MSNA activity was not significantly different between sequences. Conclusion: Acute right cymba aLL-tVNS did not induce any overall effects neither on heart rate, HRV nor MSNA variables on healthy subjects when compared to active control. Interestingly, these findings questioned the role of active controls in medical device clinical trials that implied subjective endpoints.
format Online
Article
Text
id pubmed-7744823
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-77448232020-12-18 Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography Gauthey, Anaïs Morra, Sofia van de Borne, Philippe Deriaz, Denis Maes, Nathalie le Polain de Waroux, Jean-Benoît Front Physiol Physiology Introduction: Auricular low-level transcutaneous vagus nerve stimulation (aLL-tVNS) has emerged as a promising technology for cardiac arrhythmia management but is still experimental. In this physiological study, we hypothesized that aLL-tVNS modulated the autonomic nervous balance through a reduction of sympathetic tone and an increase in heart rate variability (HRV). We investigated the muscle sympathetic nerve activity (MSNA) recorded by microneurography during vagally mediated aLL-tVNS and active control on healthy volunteers. Methods: In this crossover, double-blind controlled study, healthy men (N = 28; 27 ± 4 years old) were assigned to aLL-tVNS applied to cymba and lobe (active control) of the right ear. Each participant was randomly allocated to the three sequences (5 Hz, 20 Hz, and active control-5 Hz) during one session. MSNA signal was recorded at rest, during voluntarily apnea and aLL-tVNS. Sympathetic activity was expressed as: 1) number of bursts per minute (burst frequency, BF) and 2) MSNA activity calculated as BF x mean burst amplitude and expressed as changes from baseline (%). RR intervals, HRV parameters and sympathetic activity were analyzed during 5 min-baseline, 10 min-stimulation, and 10 min-recovery periods. Mixed regression models were performed to evaluate cymba-(5—20 Hz) effects on the parameters with stimulation. Results: During apnea and compared to baseline, BF and MSNA activity increased (p = 0.002, p = 0.001, respectively). No stimulation effect on RR intervals and HRV parameters were showed excepted a slightly increase of the LF/HF ratio with stimulation in the cymba-5Hz sequence (coef. ± SE: 0.76 ± 0.32%; p = 0.02). During stimulation, reductions from baseline in BF (Coef. ± SE: −4.8 ± 1.1, p < 0.001) was observed but was not statistically different from that one in the active control. Reduction of MSNA activity was not significantly different between sequences. Conclusion: Acute right cymba aLL-tVNS did not induce any overall effects neither on heart rate, HRV nor MSNA variables on healthy subjects when compared to active control. Interestingly, these findings questioned the role of active controls in medical device clinical trials that implied subjective endpoints. Frontiers Media S.A. 2020-12-03 /pmc/articles/PMC7744823/ /pubmed/33343394 http://dx.doi.org/10.3389/fphys.2020.599896 Text en Copyright © 2020 Gauthey, Morra, van de Borne, Deriaz, Maes and le Polain de Waroux. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Physiology
Gauthey, Anaïs
Morra, Sofia
van de Borne, Philippe
Deriaz, Denis
Maes, Nathalie
le Polain de Waroux, Jean-Benoît
Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography
title Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography
title_full Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography
title_fullStr Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography
title_full_unstemmed Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography
title_short Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography
title_sort sympathetic effect of auricular transcutaneous vagus nerve stimulation on healthy subjects: a crossover controlled clinical trial comparing vagally mediated and active control stimulation using microneurography
topic Physiology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7744823/
https://www.ncbi.nlm.nih.gov/pubmed/33343394
http://dx.doi.org/10.3389/fphys.2020.599896
work_keys_str_mv AT gautheyanais sympatheticeffectofauriculartranscutaneousvagusnervestimulationonhealthysubjectsacrossovercontrolledclinicaltrialcomparingvagallymediatedandactivecontrolstimulationusingmicroneurography
AT morrasofia sympatheticeffectofauriculartranscutaneousvagusnervestimulationonhealthysubjectsacrossovercontrolledclinicaltrialcomparingvagallymediatedandactivecontrolstimulationusingmicroneurography
AT vandebornephilippe sympatheticeffectofauriculartranscutaneousvagusnervestimulationonhealthysubjectsacrossovercontrolledclinicaltrialcomparingvagallymediatedandactivecontrolstimulationusingmicroneurography
AT deriazdenis sympatheticeffectofauriculartranscutaneousvagusnervestimulationonhealthysubjectsacrossovercontrolledclinicaltrialcomparingvagallymediatedandactivecontrolstimulationusingmicroneurography
AT maesnathalie sympatheticeffectofauriculartranscutaneousvagusnervestimulationonhealthysubjectsacrossovercontrolledclinicaltrialcomparingvagallymediatedandactivecontrolstimulationusingmicroneurography
AT lepolaindewarouxjeanbenoit sympatheticeffectofauriculartranscutaneousvagusnervestimulationonhealthysubjectsacrossovercontrolledclinicaltrialcomparingvagallymediatedandactivecontrolstimulationusingmicroneurography