scholarly journals Inspiratory- and expiratory-gated transcutaneous vagus nerve stimulation have different effects on heart rate in healthy subjects: preliminary results

2019 ◽  
Author(s):  
Bartłomiej Paleczny ◽  
Rafał Seredyński ◽  
Beata Ponikowska
Keyword(s):  
Heart Rate ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Healthy Subjects ◽  
Preliminary Results ◽  
Transcutaneous Vagus Nerve Stimulation

scholarly journals 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

2020 ◽  
Vol 11 ◽  
Author(s):  
Anaïs Gauthey ◽  
Sofia Morra ◽  
Philippe van de Borne ◽  
Denis Deriaz ◽  
Nathalie Maes ◽  
...  
Keyword(s):  
Heart Rate ◽  
Vagus Nerve ◽  
Active Control ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Sympathetic Activity ◽  
Healthy Subjects ◽  
Controlled Study ◽  
Rr Intervals ◽  
Transcutaneous Vagus Nerve Stimulation

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.

Bursted auricular vagus nerve stimulation alters heart rate variability in healthy subjects

2021 ◽  
Author(s):  
Jozsef Constantin Széles ◽  
Stefan Kampusch ◽  
Florian Thürk ◽  
Christian Clodi ◽  
Norbert Thomas ◽  
...  
Keyword(s):  
Heart Rate ◽  
Heart Rate Variability ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Healthy Subjects

scholarly journals Cardiac and Peripheral Autonomic Responses to Orthostatic Stress During Transcutaneous Vagus Nerve Stimulation in Healthy Subjects

2019 ◽  
Vol 8 (4) ◽  
pp. 496 ◽  
Author(s):  
Eleonora Tobaldini ◽  
Edgar Toschi-Dias ◽  
Liliane Appratto de Souza ◽  
Karina Rabello Casali ◽  
Marco Vicenzi ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Healthy Subjects ◽  
Systolic Arterial Pressure ◽  
Pulse Frequency ◽  
Autonomic Control ◽  
Orthostatic Stress ◽  
Transcutaneous Vagus Nerve Stimulation ◽  
Sympathetic Modulation

Previous studies showed that transcutaneous vagus nerve stimulation (tVNS) modulates the autonomic nervous system (ANS) in resting condition. However, the autonomic regulation in response to an orthostatic challenge during tVNS in healthy subjects remains unknown. We tested the hypothesis that tVNS reduces heart rate (HR) and alters the responsivity of ANS to orthostatic stress in healthy subjects. In a randomized and cross-over trial, thirteen healthy subjects underwent two experimental sessions on different days: (1) tVNS and (2) control. Using a tVNS device, an auricular electrode was placed on the left cymba conchae of the external ear; an electric current with a pulse frequency of 25 Hz and amplitude between 1 and 6 mA was applied. For the assessment of ANS, the beat-to-beat HR and systolic arterial pressure (SAP) were analyzed using linear and nonlinear approaches during clinostatic and orthostatic conditions. In clinostatic conditions, tVNS reduced HR (p < 0.01), SAP variability (p < 0.01), and cardiac and peripheral sympathetic modulation (p < 0.01). The responsivity of the peripheral sympathetic modulation to orthostatic stress during tVNS was significantly higher when compared to the control session (p = 0.03). In conclusion, tVNS reduces the HR and affects cardiac and peripheral autonomic control and increases the responses of peripheral autonomic control to orthostatic stress in healthy subjects.

scholarly journals Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Charles Ethan Paccione ◽  
Lien My Diep ◽  
Audun Stubhaug ◽  
Henrik Børsting Jacobsen
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Heart Rate Variability ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Controlled Trial ◽  
Vagal Nerve ◽  
Randomized Controlled ◽  
Transcutaneous Vagus Nerve Stimulation

Abstract Background Chronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different noninvasive vagal nerve stimulation techniques for the treatment of FM. Methods The study will use a randomized, single-blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRB™) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N = 112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N = 56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N = 56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography-measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life. Discussion The described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited. Trial registration ClinicalTrials.govNCT03180554. Registered on August 06, 2017.

scholarly journals Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Charles Ethan Paccione ◽  
Lien My Diep ◽  
Audun Stubhaug ◽  
Henrik Børsting Jacobsen
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Heart Rate Variability ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Controlled Trial ◽  
Vagal Nerve ◽  
Randomized Controlled ◽  
Transcutaneous Vagus Nerve Stimulation

Abstract BackgroundChronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different non-invasive vagal nerve stimulation techniques for the treatment of FM.MethodsThe study will use a randomized, single blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRBTM) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N=112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N=56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N=56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pain-pressure limit determined by computerized pressure cuff algometry, blood pressure, and health related quality of life.DiscussionThe described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited.Trial registrationClinicalTrials.gov Identifier: NCT03180554; Date of Registration: 08/06/2017

scholarly journals The Effect of Transcutaneous Vagus Nerve Stimulation in Patients with Polymyalgia Rheumatica

2021 ◽  
Vol 14 (11) ◽  
pp. 1166
Author(s):  
Jacob Venborg ◽  
Anne-Marie Wegeberg ◽  
Salome Kristensen ◽  
Birgitte Brock ◽  
Christina Brock ◽  
...  
Keyword(s):  
Heart Rate ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Polymyalgia Rheumatica ◽  
Vagus Nerve Stimulation ◽  
Patient Reported Outcome ◽  
Long Term Effects ◽  
Transcutaneous Vagus Nerve Stimulation ◽  
Patient Reported ◽  
Treatment Naïve

(1) Polymyalgia rheumatica (PMR) is an inflammatory disease characterised by pain, morning stiffness, and reduced quality of life. Recently, vagus nerve stimulation (VNS) was shown to have anti-inflammatory effects. We aimed to examine the effect of transcutaneous VNS (t-VNS) on PMR. (2) Fifteen treatment-naïve PMR patients completed the study. Patients underwent a 5-day protocol, receiving 2 min of t-VNS stimulation bilaterally on the neck, three times daily. Cardiac vagal tone (CVT) measured on a linear vagal scale (LVS), blood pressure, heart rate, patient-reported outcome, and biochemical changes were assessed. (3) t-VNS induced a 22% increase in CVT at 20 min after initial stimulations compared with baseline (3.4 ± 2.2 LVS vs. 4.1 ± 2.9 LVS, p = 0.02) and was accompanied by a 4 BPM reduction in heart rate (73 ± 11 BPM vs. 69 ± 9, p < 0.01). No long-term effects were observed. Furthermore, t-VNS induced a 14% reduction in the VAS score for the hips at day 5 compared with the baseline (5.1 ± 2.8 vs. 4.4 ± 2.8, p = 0.04). No changes in CRP or proinflammatory analytes were observed. (4) t-VNS modulates the autonomic nervous system in patients with PMR, but further investigation of t-VNS in PMR patients is warranted.

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