Clinical trial NCT02603991: Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
Official title: Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epileptic Encephalopathy
Keywords: children and adolescents
Prospective cohort study
vagus nerve stimulation
PINS
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 1
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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

Eligibility criteria: 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.

Primary outcomes:
measure: The change of the score in Quality of Life in Children with Epilepsy
timeFrame: QOLCE Scores at 3,6,9,12,18, 24 month of stimulation
Secondary outcomes:
measure: Respondent rate
timeFrame: Respondent rate at 3,6,9,12,24 month
measure: seizure free rate
timeFrame: seizure free rate at 3,6,9,12, 24 month
measure: complication
timeFrame: complication at 3,6,9,12, 24 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jianguo Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: