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

Primary Purpose

Refractory Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PINS Vagus Nerve Stimualtor
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Epilepsy

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental

Control

Arm Description

Subjects'Vagus Nerve stimulator is on always

Subjects'Vagus Nerve stimulator is off from enrollment to 3 month

Outcomes

Primary Outcome Measures

Changes in seizure frequency

Secondary Outcome Measures

Changes in seizure frequency
Engel scale description
Changes in the Number of Anti-epileptic Drugs
GESELL mental development scales

Full Information

First Posted
February 15, 2017
Last Updated
December 29, 2017
Sponsor
Beijing Pins Medical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03062514
Brief Title
Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
Official Title
Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Subjects'Vagus Nerve stimulator is on always
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Subjects'Vagus Nerve stimulator is off from enrollment to 3 month
Intervention Type
Device
Intervention Name(s)
PINS Vagus Nerve Stimualtor
Intervention Description
PINS Vagus Nerve Stimualtor
Primary Outcome Measure Information:
Title
Changes in seizure frequency
Time Frame
12 weeks of stimulation
Secondary Outcome Measure Information:
Title
Changes in seizure frequency
Time Frame
6、12、24 weeks of stimulation
Title
Engel scale description
Time Frame
6、12、24 weeks of stimulation
Title
Changes in the Number of Anti-epileptic Drugs
Time Frame
6、12、24 weeks of stimulation
Title
GESELL mental development scales
Time Frame
12、24 weeks of stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 3-6 At least 6 seizure per month Refractory Epilepsy In good health except epilepsy Patients or his(her) familyscould understand this method and sign the informed consent Patients with good compliance and could complete postoperative follow-up Exclusion Criteria: Results of MRI remind epilepsy caused by intracranial space-occupying lesions The vagus nerve lesion and damage Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication Cann't write the epilepsy diary Participating other clinical trial Cann't complate the operation Complete the postoperative follow-up Cann't complete the promgramming
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fumin Jia, PhD
Phone
010-60736388
Email
pins_medical@163.con
First Name & Middle Initial & Last Name or Official Title & Degree
Luming Li, PhD
Phone
010-80699200
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuwu Jiang, MD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liping Zou
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jianxiang Liao
Organizational Affiliation
Shenzhen Children's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qian Chen
Organizational Affiliation
Children's Hospital of The Capital Institute of Pediatrics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Baomin Li
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yuxing Gao
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jianmin Liang
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shaoping Huang
Organizational Affiliation
Second Affiliated Hospital of Xi'an Jiaotong University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fei Yin
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Feng Gao
Organizational Affiliation
The Children's Hospital of Zhejiang University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yanhui Chen
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
XiaoMei SHU
Organizational Affiliation
Zunyi Medical College
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hua Yu
Organizational Affiliation
Shengjing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuwu Jiang
Phone
010-83573228

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35833911
Citation
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.
Results Reference
derived
PubMed Identifier
30642370
Citation
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.
Results Reference
derived

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

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