机构:[1]China Acad Chinese Med Sci, Inst Acupuncture & Moxibust, Beijing 100700, Peoples R China;[2]Hubei Univ Chinese Med, Innovat Ctr Prevent Treatment Acupuncture & Moxib, Wuhan 430061, Peoples R China;[3]Capital Med Univ, Beijing Tian Tan Hosp, Beijing 100050, Peoples R China;[4]Capital Med Univ, Beijing Children Hosp, Beijing 100045, Peoples R China;首都医科大学附属北京儿童医院[5]China Acad Chinese Med Sci, Clin Evaluat Ctr, Inst Basic Res Clin Med, Beijing 100700, Peoples R China
Background: Recently, 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/Design: A 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. Discussion: Results 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.
基金:
National Natural Science Foundation of ChinaNational Natural Science Foundation of China [81273829]; National Basic Research Program (973 Program)National Basic Research Program of China [2011CB505201]; Beijing Natural Science FoundationBeijing Natural Science Foundation [7102120]; Fundamental Research Funds for the Central Public Welfare Research Institutes [ZZKF08004]
第一作者机构:[1]China Acad Chinese Med Sci, Inst Acupuncture & Moxibust, Beijing 100700, Peoples R China;[2]Hubei Univ Chinese Med, Innovat Ctr Prevent Treatment Acupuncture & Moxib, Wuhan 430061, Peoples R China;
通讯作者:
通讯机构:[1]China Acad Chinese Med Sci, Inst Acupuncture & Moxibust, Beijing 100700, Peoples R China;[2]Hubei Univ Chinese Med, Innovat Ctr Prevent Treatment Acupuncture & Moxib, Wuhan 430061, Peoples R China;
推荐引用方式(GB/T 7714):
He Wei,Wang Xiao-Yu,Zhou Li,et al.Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial[J].TRIALS.2015,16(1):-.doi:10.1186/s13063-015-0906-8.
APA:
He, Wei,Wang, Xiao-Yu,Zhou, Li,Li, Zhi-Mei,Jing, Xiang-Hong...&Zhu, Bing.(2015).Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial.TRIALS,16,(1)
MLA:
He, Wei,et al."Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial".TRIALS 16..1(2015):-