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

Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)

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.

Study Overview

• Status: Unknown
• Conditions: Refractory Epilepsy
• Intervention / Treatment: Device: PINS Vagus Nerve Stimualtor

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University First Hospital
      • Contact: Yuwu Jiang; Phone Number: 010-83573228

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 3-6
2. At least 6 seizure per month
3. Refractory Epilepsy
4. In good health except epilepsy
5. Patients or his(her) familyscould understand this method and sign the informed consent
6. Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria:

1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions
2. The vagus nerve lesion and damage
3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication
4. Cann't write the epilepsy diary
5. Participating other clinical trial
6. Cann't complate the operation
7. Complete the postoperative follow-up
8. Cann't complete the promgramming

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Subjects'Vagus Nerve stimulator is on always	Device: PINS Vagus Nerve Stimualtor; PINS Vagus Nerve Stimualtor
Sham Comparator: Control; Subjects'Vagus Nerve stimulator is off from enrollment to 3 month	Device: PINS Vagus Nerve Stimualtor; PINS Vagus Nerve Stimualtor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in seizure frequency	12 weeks of stimulation

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in seizure frequency	6、12、24 weeks of stimulation
Engel scale description	6、12、24 weeks of stimulation
Changes in the Number of Anti-epileptic Drugs	6、12、24 weeks of stimulation
GESELL mental development scales	12、24 weeks of stimulation

Collaborators and Investigators

• Sponsor: Beijing Pins Medical Co., Ltd
• Investigators: Principal Investigator: Yuwu Jiang, MD, Peking University First Hospital; Study Director: Liping Zou, Chinese PLA General Hospital; Study Director: Jianxiang Liao, Shenzhen Children's Hospital; Study Director: Qian Chen, Children's Hospital of The Capital Institute of Pediatrics; Study Director: Baomin Li, Qilu Hospital of Shandong University; Study Director: Yuxing Gao, Shandong Provincial Hospital; Study Director: Jianmin Liang, The First Hospital of Jilin University; Study Director: Shaoping Huang, Second Affiliated Hospital of Xi'an JiaoTong University; Study Director: Fei Yin, Xiangya Hospital of Central South University; Study Director: Feng Gao, The Children's Hospital of Zhejiang University School of Medicine; Study Director: Yanhui Chen, Fujian Medical University Union Hospital; Study Director: XiaoMei SHU, Zunyi Medical College; Study Director: Hua Yu, Shengjing Hospital

Publications and helpful links

General Publications

• Panebianco M, Rigby A, Marson AG. Vagus nerve stimulation for focal seizures. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD002896. doi: 10.1002/14651858.CD002896.pub3.
• Ji T, Yang Z, Liu Q, Liao J, Yin F, Chen Y, Zou L, Li B, Gao Y, Shu X, Huang S, Gao F, Liang J, Lin SF, Peng J, Song S, Wang J, Che C, Sun W, Tian M, Yang L, Hua Y, Hao Y, Cai L, Li L, Jiang Y. 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. Trials. 2019 Jan 14;20(1):44. doi: 10.1186/s13063-018-3087-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 29, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: PINS-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No