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
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
Affiliations
Taoyun Ji
Division of Pediatric Neurology, Pediatrics Department, Peking University First Hospital
Zhao Yang
National Engineering Laboratory for Neuromodulation, School of Aerospace Engineering, Tsinghua University
Qingzhu Liu
Department of Pediatric Epilepsy Center, Peking University First Hospital
Jianxiang Liao
Department of Neurology, Shenzhen Children’s Hospital
Fei Yin
Department of Pediatrics, Xiangya Hospital of Central South University
Yanhui Chen
Division of Pediatric Neurology, Pediatrics Department, Fujian Medical University Union Hospital
Liping Zou
Department of Pediatric, Chinese PLA General Hospital
Baomin Li
Pediatics Department, Qilu Hospital of Shandong University
Yuxing Gao
Division of Pediatrics Neurology, Provincial Hospital Affiliated to Shandong University
Xiaomei Shu
Department of Pediatrics, Affiliated Hospital of Zunyi Medical College
Shaoping Huang
Department of Pediatrics, The Second Affiliated Hospital of Xi’an Jiaotong University
Feng Gao
Department of Neurology, The Children’s Hospital, ZheJiang University School of Medicine
Jianmin Liang
Department of Pediatric Neurology, First Bethune Hospital, Jilin University
Su Fang Lin
Department of Neurology, Shenzhen Children’s Hospital
Jing Peng
Department of Pediatrics, Xiangya Hospital of Central South University
Shiwei Song
Department of Epilepsy Center, Fujian Medical University Union Hospital
Jing Wang
Department of Pediatric, Chinese PLA General Hospital
Chao Che
Pediatics Department, Qilu Hospital of Shandong University
Wenxiu Sun
Division of Pediatrics Neurology, Provincial Hospital Affiliated to Shandong University
Maoqiang Tian
Department of Pediatrics, Affiliated Hospital of Zunyi Medical College
Lin Yang
Department of Pediatrics, The Second Affiliated Hospital of Xi’an Jiaotong University
Yi Hua
Department of Neurology, The Children’s Hospital, ZheJiang University School of Medicine
Yunpeng Hao
Department of Pediatric Neurology, First Bethune Hospital, Jilin University
Lixin Cai
Department of Pediatric Epilepsy Center, Peking University First Hospital
Luming Li
National Engineering Laboratory for Neuromodulation, School of Aerospace Engineering, Tsinghua University
Yuwu Jiang
Division of Pediatric Neurology, Pediatrics Department, Peking University First Hospital
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.
