Abstract
BackgroundRecently, clinical observations reported the potential benefit of vagus nerve stimulation (VNS) for pediatric epilepsy. Transcutaneous auricular vagus nerve stimulation (ta-VNS) is a newer non-invasive VNS, making it more accessible for treating pediatric epilepsy, yet there is limited clinical evidence for its effectiveness.Methods/DesignA three-center, randomized, parallel, controlled trial will be carried out to evaluate whether ta-VNS improves pediatric epilepsy. Pediatric patients aged 2 to 14 years with epilepsy will be recruited and randomly assigned to transcutaneous auricular vagus nerve stimulation (ta-VNS) group, transcutaneous auricular non-vagus nerve stimulation (tan-VNS) group, and control group with a 1:1: sqrt(2) allocation, as per a computer generated randomization schedule stratified by study center using permuted blocks of random sizes. We will use Zelen’s design, in which randomization occurs before informed consent. Patients in the stimulation groups will receive tan-VNS or ta-VNS three times a day for 6 months. Patients in the control group will not be provided with any stimulation during the 6 months. The guardians of the patients are required to keep a detailed diary to record the data. Outcome assessment including seizure frequency, electroencephalogram (EEG), heart rate variability (HRV) analysis, quality of life (QOL) and adverse events will be made at baseline and 2, 4 and 6 months after ta-VNS initiation. The seizure frequency and adverse events will be followed up at 1 year and 1.5 years after ta-VNS initiation.DiscussionResults of this trial will help clarify whether ta-VNS treatment is beneficial for pediatric patients, and will make clear whether the anticonvulsive effect of ta-VNS is correlated with the improvement of sympathovagal imbalance.Trial registrationClinical Trials Identifier: NCT02004340. Registration date: 13 November 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0906-8) contains supplementary material, which is available to authorized users.
Highlights
Clinical observations reported the potential benefit of vagus nerve stimulation (VNS) for pediatric epilepsy
Results of this trial will help clarify whether Transcutaneous auricular vagus nerve stimulation (ta-Vagus nerve stimulation (VNS)) treatment is beneficial for pediatric patients, and will make clear whether the anticonvulsive effect of ta-VNS is correlated with the improvement of sympathovagal imbalance
We aim to investigate the safety and efficacy of ta-VNS in treating pediatric patients with epilepsy in a multicenter randomized controlled trial (RCT), and determine whether the anticonvulsive effect of taVNS is correlated with the improvement of sympathovagal imbalance
Summary
Clinical observations reported the potential benefit of vagus nerve stimulation (VNS) for pediatric epilepsy. Transcutaneous auricular vagus nerve stimulation (ta-VNS) is a newer non-invasive VNS, making it more accessible for treating pediatric epilepsy, yet there is limited clinical evidence for its effectiveness. Clinical observations indicated the potential benefit of VNS for pediatric epilepsy. He et al Trials (2015) 16:371 adult patients, after 24 weeks’ treatment of ta-VNS, 8/47 patients were seizure-free; 19/47 patients had reduced seizure frequency [5]. In our pilot trial of ta-VNS for pediatric epilepsy, mean reduction in seizure frequency relative to baseline was 54.13 % at the end of 24 weeks’ treatment [7]. No randomized controlled trial (RCT) has been performed on the safety and efficacy of ta-VNS for patients with pediatric epilepsy
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