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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02603991

Enrollment

Registered

2015-11-13

Start date

2016-06-30

Completion date

2017-10-31

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epileptic Encephalopathy

Keywords

children and adolescents, Prospective cohort study, vagus nerve stimulation, PINS

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

Interventions

PROCEDUREPINS Vagus Nerve Stimulator

The stimulators are implanted in the body,with the stimulation of the IPG

DRUGLevetiracetam

The best anti-epileptic drugs to patients who participate in this study，Levetiracetam，

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
seizure free rate	seizure free rate at 3,6,9,12, 24 month
complication	complication at 3,6,9,12, 24 month
Respondent rate	Respondent rate at 3,6,9,12,24 month

Countries

China

Contacts

Primary ContactFumin Jia, PhD

+86-010-59361265

Backup ContactLuming Li, PhD

+86 010-60736388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026