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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Antiepileptic Drugs | Study protocol

Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial

Authors: Taoyun Ji, Zhao Yang, Qingzhu Liu, Jianxiang Liao, Fei Yin, Yanhui Chen, Liping Zou, Baomin Li, Yuxing Gao, Xiaomei Shu, Shaoping Huang, Feng Gao, Jianmin Liang, Su Fang Lin, Jing Peng, Shiwei Song, Jing Wang, Chao Che, Wenxiu Sun, Maoqiang Tian, Lin Yang, Yi Hua, Yunpeng Hao, Lixin Cai, Luming Li, Yuwu Jiang

Published in: Trials | Issue 1/2019

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Abstract

Background

Recent clinical observations have reported the potential benefit of vagus nerve stimulation (VNS) as an adjunctive therapy for pediatric epilepsy. Preliminary evidence suggests that VNS treatment is effective for seizure reduction and mental development in young participants between 3 and 6 years of age who suffer from intractable epilepsy. However, robust clinical evidence for quantifying the difference of the efficacy and safety of VNS treatment in this specific patient population has yet to be reported.

Methods/design

A two-armed, multicenter, randomized, double-blind, prospective trial will be carried out to evaluate whether VNS is beneficial and safe for pediatric epilepsy. Pediatric participants aged between 3 to 6 years old with intractable epilepsy will be recruited and randomly assigned to experimental and control groups with a 1:1 allocation using a computer-generating randomization schedule. Before enrollment, informed consent will be signed by the parents of the participants and the study researchers. Participants in the experimental group will receive electrical stimulation over 24 weeks under standard stimulation parameters. Participants in the control group will not receive any stimulation during the 12 weeks of the double-blind period. The guardians of the participants are required to keep a detailed diary to record seizure activity. Outcome assessments including seizure frequency, Gesell Mental Developmental Scale scores, use of antiepileptic drugs and dosages, and adverse events will be collected at baseline, 6, 12, 18 and/or 24 weeks after electrical stimulation is initiated. The effects of treatment will be analyzed with time and treatment group comparisons.

Discussion

This trial will evaluate quantitative differences in efficacy and safety with/without VNS treatment for pediatric participants aged between 3 to 6 years with intractable epilepsy and will explore whether the current age range of VNS therapy can be expanded.

Trial registration

ClinicalTrials.gov, ID: NCT03062514, Registered on 23 February 2017.
Appendix
Available only for authorised users
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Metadata
Title
Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial
Authors
Taoyun Ji
Zhao Yang
Qingzhu Liu
Jianxiang Liao
Fei Yin
Yanhui Chen
Liping Zou
Baomin Li
Yuxing Gao
Xiaomei Shu
Shaoping Huang
Feng Gao
Jianmin Liang
Su Fang Lin
Jing Peng
Shiwei Song
Jing Wang
Chao Che
Wenxiu Sun
Maoqiang Tian
Lin Yang
Yi Hua
Yunpeng Hao
Lixin Cai
Luming Li
Yuwu Jiang
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3087-4

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