NCT02603991
Unknown
Not Applicable
Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
ConditionsEpileptic Encephalopathy
DrugsLevetiracetam
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epileptic Encephalopathy
- Sponsor
- Beijing Pins Medical Co., Ltd
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- The change of the score in Quality of Life in Children with Epilepsy
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
The change of the score in Quality of Life in Children with Epilepsy
Time Frame: QOLCE Scores at 3,6,9,12,18, 24 month of stimulation
Secondary Outcomes
- 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)
Study Sites (1)
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