scholarly journals NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Anne van der Meij ◽  
Marianne A. A. van Walderveen ◽  
Nyika D. Kruyt ◽  
Erik W. van Zwet ◽  
Eric J. Liebler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Vagus Nerve ◽  
Randomized Clinical Trial ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Standard Treatment ◽  
Infarct Volume ◽  
Non Invasive ◽  
Link Type

Abstract Background Secondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. In animal models, vagus nerve stimulation (VNS) inhibits these detrimental changes and thereby reduces tissue injury. The aim of this study is to investigate whether non-invasive cervical VNS (nVNS) in addition to the current standard treatment can improve penumbral recovery and limit final infarct volume. Methods NOVIS is a single-center prospective randomized clinical trial with blinded outcome assessment. One hundred fifty patients will be randomly allocated (1:1) within 12 h from clinical stroke onset to nVNS for 5 days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day 5 assessed with MRI. Discussion We hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery. The results of this study will be used to assess the viability and approach to power a larger trial to more definitively assess the clinical efficacy of nVNS after stroke. Trial registration ClinicalTrials.govNCT04050501. Registered on 8 August 2019

scholarly journals Effect of Transcutaneous Vagus Nerve Stimulation at Auricular Concha for Insomnia: A Randomized Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Yue Jiao ◽  
Xiao Guo ◽  
Man Luo ◽  
Suxia Li ◽  
Aihua Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vagus Nerve ◽  
Randomized Clinical Trial ◽  
Scale Score ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Short Form ◽  
Hamilton Depression Scale ◽  
Link Type ◽  
Transcutaneous Vagus Nerve Stimulation

Insomnia inflicts mental burden and decreases physical productivity and affects life quality. Transcutaneous vagus nerve stimulation (ta-VNS) may be an effective treatment option for insomnia. This study aims to evaluate the effect and safety of ta-VNS and compare it with transcutaneous nonvagus nerve stimulation (tn-VNS). A multicenter, randomized, clinical trial was conducted at 3 hospitals in China enrolling 72 insomnia participants from May 2016 to June 2017. Participants were randomly assigned (1 : 1) to receive 40 sessions of ta-VNS or tn-VNS treatment. 63 participants completed the trial. ta-VNS treatment significantly decreased the Pittsburgh Sleep Quality Index score, Epworth Sleepiness Scale score, Flinders Fatigue Scale score, Hamilton Depression Scale score, and Hamilton Anxiety Scale score over 4 weeks compared with those of the baseline. Moreover, it also significantly increased the 36-item Short-Form Health Survey Questionnaire scores compared with that of the baseline. However, it did not show significant differences compared with tn-VNS in changes of primary and secondary outcomes. The incidence of adverse events was low. ta-VNS significantly relieved insomnia over 4 weeks. Moreover, it also alleviated fatigue and improved participants’ quality of life as well as other concomitant symptoms such as depression and anxiety. This trial is registered at Chinese Clinical Trial Registry (http://www.chictr.org.cn) with the registration number: ChiCTR-TRC-13003519.

scholarly journals Auricular Neuromodulation for Mass Vagus Nerve Stimulation: Insights From SOS COVID-19 a Multicentric, Randomized, Controlled, Double-Blind French Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Claire-Marie Rangon ◽  
Régine Barruet ◽  
Abdelmadjid Mazouni ◽  
Chloé Le Cossec ◽  
Sophie Thevenin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vagus Nerve ◽  
Clinical Outcomes ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Treated Patient ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Non Invasive ◽  
The Impact

Importance: An exacerbated inflammatory response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is believed to be one of the major causes of the morbidity and mortality of the coronavirus disease 2019 (COVID-19). Neuromodulation therapy, based on vagus nerve stimulation, was recently hypothesized to control both the SARS-CoV-2 replication and the ensuing inflammation likely through the inhibition of the nuclear factor kappa-light-chain-enhancer of activated B cells pathway and could improve the clinical outcomes as an adjunct treatment. We proposed to test it by the stimulation of the auricular branch of the vagus nerve, i.e., auricular neuromodulation (AN), a non-invasive procedure through the insertion of semipermanent needles on the ears.Objective: The aim of this study was to assess the effect of AN on the clinical outcomes in patients affected by COVID-19.Design, Setting, and Participants: A multicenter, randomized, placebo-controlled, double-blind clinical trial included 31 patients with respiratory failure due to COVID-19 requiring hospitalization. Within 72 h after admission, patients received either AN (n = 14) or sham neuromodulation (SN, n = 15) in addition to the conventional treatments.Main Outcome and Measures: The primary endpoint of the study was the rate of a clinical benefit conferred by AN at Day 14 (D14) as assessed by a 7-point Clinical Progression Scale. The secondary endpoint of the study was the impact of AN on the rate of transfer to the intensive care unit (ICU) and on the survival rate at D14.Results: The AN procedure was well-tolerated without any reported side effects but with no significant improvement for the measures of both primary (p > 0.3) and secondary (p > 0.05) endpoints at the interim analysis. None of the AN-treated patients died but one in the SN group did (81 years). Two AN-treated patients (73 and 79 years, respectively) and one SN-treated patient (59 years) were transferred to ICU. Remarkably, AN-treated patients were older with more representation by males than in the SN arm (i.e., the median age of 75 vs. 65 years, 79% male vs. 47%).Conclusion: The AN procedure, which was used within 72 h after the admission of patients with COVID-19, was safe and could be successfully implemented during the first two waves of COVID-19 in France. Nevertheless, AN did not significantly improve the outcome of the patients in our small preliminary study. It is pertinent to explore further to validate AN as the non-invasive mass vagal stimulation solution for the forthcoming pandemics.Clinical Trial Registration: [https://clinicaltrials.gov/], identifier [NCT04341415].

scholarly journals Non-invasive vagus nerve stimulation reduced neuron-derived IL-1β and neuroinflammation in acute ischemic rat brain

2021 ◽  
Author(s):  
Lisa Y Yang ◽  
Kiran Bhaskar ◽  
Jeffrey Thompson ◽  
Kelsey Duval ◽  
Michel Torbey ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Rat Brain ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Non Invasive

scholarly journals Non-invasive vagus nerve stimulation boosts mood recovery after effort exertion

2021 ◽  
pp. 1-11
Author(s):  
Magdalena Ferstl ◽  
Vanessa Teckentrup ◽  
Wy Ming Lin ◽  
Franziska Kräutlein ◽  
Anne Kühnel ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Positive Mood ◽  
Credible Interval ◽  
Cognitive Effort ◽  
Mood States ◽  
Non Invasive ◽  
Lower Baseline ◽  
Open Question

Abstract Background Mood plays an important role in our life which is illustrated by the disruptive impact of aberrant mood states in depression. Although vagus nerve stimulation (VNS) has been shown to improve symptoms of depression, the exact mechanism is still elusive, and it is an open question whether non-invasive VNS could be used to swiftly and robustly improve mood. Methods Here, we investigated the effect of left- and right-sided transcutaneous auricular VNS (taVNS) v. a sham control condition on mood after the exertion of physical and cognitive effort in 82 healthy participants (randomized cross-over design) using linear mixed-effects and hierarchical Bayesian analyses of mood ratings. Results We found that 90 min of either left-sided or right-sided taVNS improved positive mood [b = 5.11, 95% credible interval, CI (1.39–9.01), 9.6% improvement relative to the mood intercept, BF10 = 7.69, pLME = 0.017], yet only during the post-stimulation phase. Moreover, lower baseline scores of positive mood were associated with greater taVNS-induced improvements in motivation [r = −0.42, 95% CI (−0.58 to −0.21), BF10 = 249]. Conclusions We conclude that taVNS boosts mood after a prolonged period of effort exertion with concurrent stimulation and that acute motivational effects of taVNS are partly dependent on initial mood states. Collectively, our results show that taVNS may help quickly improve affect after a mood challenge, potentially by modulating interoceptive signals contributing to the reappraisal of effortful behavior. This suggests that taVNS could be a useful add-on to current behavioral therapies.

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