Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

Not Applicable

• Conditions: Epilepsy
• Interventions: Device: ear vagus nerve stimulator

• Registration Number: NCT02004340
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-13
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Diagnosed as epilepsy;
• With age between 2-18 years old;
• The number and dose of the medication was kept constant no less than eight weeks before intervention;
• The patients or their guardians can count the frequency of the seizures and finish the study.

Exclusion Criteria

• The patient is receiving the VNS therapy;
• Accompanied with progressive central nervous system diseases;
• Have severe heart, liver ,kidney or blood diseases;
• Be pregnant or having the schedule of pregnancy in the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous auricular vagal stimulation	ear vagus nerve stimulator	Transcutaneous stimulation at auricular concha
Transcutaneous auricular non-vagal stimulation	ear vagus nerve stimulator	Transcutaneous stimulation at auricular edge

Primary Outcome Measures

Name	Time	Method
frequency of epileptic seizures	Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks"

Trial Locations

Locations (1)

Wei He; 🇨🇳 Beijing, China