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Mendeley readers
| Title |
Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial
|
|---|---|
| Published in |
Trials, August 2015
|
| DOI | 10.1186/s13063-015-0906-8 |
| Pubmed ID | |
| Authors |
Wei He, Xiao-Yu Wang, Li Zhou, Zhi-Mei Li, Xiang-Hong Jing, Zhong-Li Lv, Yu-Feng Zhao, Hong Shi, Ling Hu, Yang-Shuai Su, Bing Zhu |
| Abstract |
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. 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. 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. NCT02004340 . Registration date: 13 November 2013. |
Mendeley readers
The data shown below were compiled from readership statistics for 136 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 1 | <1% |
| Ethiopia | 1 | <1% |
| Unknown | 134 | 99% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 21 | 15% |
| Student > Ph. D. Student | 19 | 14% |
| Student > Master | 15 | 11% |
| Student > Bachelor | 10 | 7% |
| Student > Postgraduate | 9 | 7% |
| Other | 17 | 13% |
| Unknown | 45 | 33% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 33 | 24% |
| Neuroscience | 10 | 7% |
| Psychology | 8 | 6% |
| Agricultural and Biological Sciences | 6 | 4% |
| Engineering | 6 | 4% |
| Other | 22 | 16% |
| Unknown | 51 | 38% |