Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
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ClinicalTrials.gov Identifier: NCT02603991
Recruitment Status : Unknown
Verified October 2016 by Beijing Pins Medical Co., Ltd. Recruitment status was: Recruiting
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
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Layout table for eligibility information
Ages Eligible for Study:
4 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients at age 4-18; diagnostic criteria for epilepsia brain disorders; having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and at least 6 seizures per month; patients or his(her) familys could understand this method and sign the informed consent; Patients with good compliance and could complete postoperative follow-up；without the vagus nerve lesion and damagement, progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases, digestive system diseases
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
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.