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| ID | Type | Description | Link |
|---|---|---|---|
| 2011CB505201 | Other Grant/Funding Number | National Basic Resaearch Program (973 Program) |
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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| Beijing Children's Hospital | OTHER |
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The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous auricular vagal stimulation | Active Comparator | Transcutaneous stimulation at auricular concha |
|
| Transcutaneous auricular non-vagal stimulation | Sham Comparator | Transcutaneous stimulation at auricular edge |
|
| control | No Intervention | No transcutaneous stimulation is given |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ear vagus nerve stimulator | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| frequency of epileptic seizures | Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei He, Dr. | Contact | 86 10 64089403 | hazel7811@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Zhu, Dr. | Institute of Acupuncture and Moxibustion, CACMS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wei He | Recruiting | Beijing | 100700 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26292720 | Derived | He W, Wang XY, Zhou L, Li ZM, Jing XH, Lv ZL, Zhao YF, Shi H, Hu L, Su YS, Zhu B. Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial. Trials. 2015 Aug 21;16:371. doi: 10.1186/s13063-015-0906-8. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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