Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy

Summary

Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Conditions

• Refractory Epilepsy

Interventions

DEVICE

PINS Vagus Nerve Stimualtor

PINS Vagus Nerve Stimualtor

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd

  lead INDUSTRY

Principal Investigators

• Yuwu Jiang, MD · Peking University First Hospital

• Liping Zou · Chinese PLA General Hospital

• Jianxiang Liao · Shenzhen Children's Hospital

• Qian Chen · Children's Hospital of The Capital Institute of Pediatrics

• Baomin Li · Qilu Hospital of Shandong University

• Yuxing Gao · Shandong Provincial Hospital

• Jianmin Liang · The First Hospital of Jilin University

• Shaoping Huang · Second Affiliated Hospital of Xi'an Jiaotong University

• Fei Yin · Xiangya Hospital of Central South University

• Feng Gao · The Children's Hospital of Zhejiang University School of Medicine

• Yanhui Chen · Fujian Medical University Union Hospital

• XiaoMei SHU · Zunyi Medical College

• Hua Yu · Shengjing Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-09

Primary Completion

2018-07-31

Completion

2019-12-31

Countries

• China

Study Locations