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Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Subjects'Vagus Nerve stimulator is on always |
|
| Control | Sham Comparator | Subjects'Vagus Nerve stimulator is off from enrollment to 3 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PINS Vagus Nerve Stimualtor | Device | PINS Vagus Nerve Stimualtor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in seizure frequency | 12 weeks of stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in seizure frequency | 6、12、24 weeks of stimulation | |
| Engel scale description | 6、12、24 weeks of stimulation | |
| Changes in the Number of Anti-epileptic Drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fumin Jia, PhD | Contact | 010-60736388 | pins_medical@163.con | |
| Luming Li, PhD | Contact | 010-80699200 |
| Name | Affiliation | Role |
|---|---|---|
| Yuwu Jiang, MD | Peking University First Hospital | Principal Investigator |
| Liping Zou | Chinese PLA General Hospital | Study Director |
| Jianxiang Liao |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35833911 | Derived | Panebianco M, Rigby A, Marson AG. Vagus nerve stimulation for focal seizures. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD002896. doi: 10.1002/14651858.CD002896.pub3. | |
| 30642370 | Derived | Ji T, Yang Z, Liu Q, Liao J, Yin F, Chen Y, Zou L, Li B, Gao Y, Shu X, Huang S, Gao F, Liang J, Lin SF, Peng J, Song S, Wang J, Che C, Sun W, Tian M, Yang L, Hua Y, Hao Y, Cai L, Li L, Jiang Y. Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial. Trials. 2019 Jan 14;20(1):44. doi: 10.1186/s13063-018-3087-4. |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 6、12、24 weeks of stimulation |
| GESELL mental development scales | 12、24 weeks of stimulation |
| Shenzhen Children's Hospital |
| Study Director |
| Qian Chen | Children's Hospital of The Capital Institute of Pediatrics | Study Director |
| Baomin Li | Qilu Hospital of Shandong University | Study Director |
| Yuxing Gao | Shandong Provincial Hospital | Study Director |
| Jianmin Liang | The First Hospital of Jilin University | Study Director |
| Shaoping Huang | Second Affiliated Hospital of Xi'an Jiaotong University | Study Director |
| Fei Yin | Xiangya Hospital of Central South University | Study Director |
| Feng Gao | The Children's Hospital of Zhejiang University School of Medicine | Study Director |
| Yanhui Chen | Fujian Medical University Union Hospital | Study Director |
| XiaoMei SHU | Zunyi Medical College | Study Director |
| Hua Yu | Shengjing Hospital | Study Director |