Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PINS Vagus Nerve Stimulator | Procedure | The stimulators are implanted in the body,with the stimulation of the IPG | ||
| Levetiracetam | Drug | The best anti-epileptic drugs to patients who participate in this study,Levetiracetam, |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fumin Jia, PhD | Contact | +86-010-59361265 | ||
| Luming Li, PhD | Contact | +86 010-60736388 |
| Name | Affiliation | Role |
|---|---|---|
| Jianguo Zhang, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
| complication at 3,6,9,12, 24 month |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |