Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)

• Conditions: Epileptic Encephalopathy

• Registration Number: NCT02603991
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief Summary

Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.

Detailed Description

Epileptic encephalopathy is very common in children and adolescent with epilepsy, but there is no data in clinical studies.The aim of this study is to evaluate the efficacy of the long-term vagus nerve stimulation for children and adolescent with epilepsy

Study Timeline

• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-13
• Study Start: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13
• Primary Completion: 2017-01
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. age 4-18
2. Diagnostic criteria for epilepsia brain disorders
3. Having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and zt least 6 seizures per month
4. patients or his(her) families could understand this method and sign the informed consent
5. Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria

1. the vagus nerve lesion and damage
2. patients with progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases,digestive system diseases
3. patients'mental state is not stable，
4. patients with or anesthesia contraindications,such as long-term use of anticoagulation antiplatelet drugs etc.
5. patients have or need other implantable devices, such as pacemakers,defibrillators, cochlear and spinal nerve root stimulator.
6. patients due to their own reasons for the need for nuclear magnetic resonance imaging in the future clinical trials
7. patients have participated in other clinical trials.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of the score in Quality of Life in Children with Epilepsy	QOLCE Scores at 3,6,9,12,18, 24 month of stimulation

Secondary Outcome Measures

Name	Time	Method
complication	complication at 3,6,9,12, 24 month
Respondent rate	Respondent rate at 3,6,9,12,24 month
seizure free rate	seizure free rate at 3,6,9,12, 24 month

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China