Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

N/AUnknownNCT02004340

China Academy of Chinese Medical Sciences120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Epilepsy

Interventions

ear vagus nerve stimulatorDEVICE

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Wei He

Beijing, China

RECRUITING

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

Time frame: participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks"

Central Contacts

Wei He, Dr.

CONTACT

86 10 64089403 hazel7811@hotmail.com

Data from ClinicalTrials.gov

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