Abstract
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.
Trial registration
Clinical Trials Identifier: NCT02004340. Registration date: 13 November 2013.
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Details
1 Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China (GRID:grid.410318.f) (ISNI:0000000406323409); Hubei University of Chinese Medicine/Innovation Center of Preventive Treatment by Acupuncture and Moxibustion, Wuhan, China (GRID:grid.34418.3a) (ISNI:0000000107279022)
2 Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China (GRID:grid.410318.f) (ISNI:0000000406323409)
3 Beijing Tian Tan Hospital, Capital Medical University, Beijing, China (GRID:grid.24696.3f) (ISNI:000000040369153X)
4 Beijing Children Hospital, Capital Medical University, Beijing, China (GRID:grid.24696.3f) (ISNI:000000040369153X)
5 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Clinical Evaluation Center, Beijing, China (GRID:grid.410318.f) (ISNI:0000000406323409)