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

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

Detailed Description
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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

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

Conditions
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Epileptic Encephalopathy

Intervention / Treatment
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* Procedure: PINS Vagus Nerve Stimulator
* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 4-18 Diagnostic criteria for epilepsia brain disorders Having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and zt least 6 seizures per month patients or his(her) families could understand this method and sign the informed consent Patients with good compliance and could complete postoperative follow-up Exclusion Criteria: the vagus nerve lesion and damage patients with progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases,digestive system diseases patients'mental state is not stable， patients with or anesthesia contraindications,such as long-term use of anticoagulation antiplatelet drugs etc. patients have or need other implantable devices, such as pacemakers,defibrillators, cochlear and spinal nerve root stimulator. patients due to their own reasons for the need for nuclear magnetic resonance imaging in the future clinical trials patients have participated in other clinical trials.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PINS Vagus Nerve Stimulator|The stimulators are implanted in the body,with the stimulation of the IPG|
|Drug: Levetiracetam|The best anti-epileptic drugs to patients who participate in this study，Levetiracetam，|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respondent rate |  | Respondent rate at 3,6,9,12,24 month | 
| seizure free rate |  | seizure free rate at 3,6,9,12, 24 month | 
| complication |  | complication at 3,6,9,12, 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children and adolescents, Prospective cohort study, vagus nerve stimulation, PINS