BACKGROUND: Recently, clinical observations reported the potential benefit of vagus nerve stimulation (VNS) for @entity302 . Transcutaneous auricular vagus nerve stimulation (ta-VNS) is a newer non-invasive VNS, making it more accessible for treating @entity302 , 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 @entity302 . Pediatric @entity1 aged 2 to 14 years with @entity302 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. @entity1 in the stimulation groups will receive tan-VNS or ta-VNS three times a day for 6 months. @entity1 in the control group will not be provided with any stimulation during the 6 months. The guardians of the @entity1 are required to keep a detailed diary to record the data. Outcome assessment including @entity410 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 @entity410 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 @entity1 , and will make clear whether the anticonvulsive effect of ta-VNS is correlated with the improvement of sympathovagal imbalance. TRIAL REGISTRATION:                 <AbstractText Label="CLINICAL TRIALS IDENTIFIER" NlmCategory="BACKGROUND">NCT02004340 . Registration date: 13 November 2013.

Transcutaneous auricular vagus nerve stimulation for XXXX : study protocol for a randomized controlled trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity410 :: ('MESH:D012640', 'Disease') :: ['seizure'] @entity302 :: ('MESH:D004827', 'Disease') :: ['pediatric epilepsy', 'epilepsy']
@entity302 :: (MESH:D004827,Disease) :: ['pediatric epilepsy']
