Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial

Table 1 Detailed schedule of the protocol

Schedule	Baseline	Treatment phase			Follow-up phase
	0 months	2 months	4 months	6 months	1 year	1.5 years
Patients
Informed consent	×
Medical history	×
Physical examination	×
Randomization	×
Intervention
ta-VNS group	Transcutaneous stimulation at the auricular concha
tan-VNS group	Transcutaneous stimulation at marginal area of the auricle
Comparison
Control group	No transcutaneous stimulation is provided
Outcomes
Seizure frequency	×	×	×	×	×	×
EEG	×			×
HRV	×			×
QOL	×			×
Safety
Adverse events	×	×	×	×	×	×

The symbol ‘x’ is used as a check mark
EEG electroencephalogram; HRV heart rate variability; QOL quality of life; ta-VNS transcutaneous auricular vagus nerve stimulation; tan-VNS transcutaneous auricular non-vagus nerve stimulation

ISSN: 1745-6215