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Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy | Clinical Trials | Clareo Health

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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)

NCT03062514•Beijing Pins Medical Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

3 - 6 years

Sex

ALL

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

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

October 9, 2017

Primary Completion Date

July 1, 2018

Completion Date

December 1, 2019

Last Updated

January 2, 2018

Enrollment

ESTIMATED participants

Conditions

Refractory Epilepsy

Interventions

PINS Vagus Nerve Stimualtor

DEVICE

Contacts

Fumin Jia, PhD

CONTACT

010-60736388 pins_medical@163.con

Luming Li, PhD

CONTACT

010-80699200

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application

Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy

The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

Optimal Stimulation Parameters to Disrupt Epileptiform Activity

Expanded Use of Cannabidiol Oral Solution

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