NCT03062514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 2, 2018

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

February 15, 2017

Last Update Submit

December 29, 2017

Conditions

Refractory Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Changes in seizure frequency

    12 weeks of stimulation

Secondary Outcomes (4)

  • 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

Study Arms (2)

Experimental

EXPERIMENTAL

Subjects'Vagus Nerve stimulator is on always

Device: PINS Vagus Nerve Stimualtor

Control

SHAM COMPARATOR

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

Device: PINS Vagus Nerve Stimualtor

Interventions

PINS Vagus Nerve StimualtorDEVICE

PINS Vagus Nerve Stimualtor

ControlExperimental

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35833911DERIVED

  • 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.

    PMID: 30642370DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Yuwu Jiang, MD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Central Study Contacts

Fumin Jia, PhD

CONTACT

010-60736388pins_medical@163.con

Luming Li, PhD

CONTACT

010-80699200

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 23, 2017

Study Start

October 9, 2017

Primary Completion

July 1, 2018

Study Completion

December 1, 2019

Last Updated

January 2, 2018

Record last verified: 2017-02

Locations

CN(1)