Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy

China Academy of Chinese Medical Sciences1 site in 1 country120 target enrollmentNovember 2013

ConditionsEpilepsy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Epilepsy
Sponsor: China Academy of Chinese Medical Sciences
Enrollment: 120
Locations: 1
Primary Endpoint: frequency of epileptic seizures
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

December 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

China Academy of Chinese Medical Sciences

Responsible Party

Principal Investigator

Wei He

Associate Professor

China Academy of Chinese Medical Sciences

Eligibility Criteria

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.

Outcomes

Primary Outcomes

frequency of epileptic seizures

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

Secondary Outcomes

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")