Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy
NCT ID: NCT02004340
Last Updated: 2015-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2013-11-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Transcutaneous auricular vagal stimulation
Transcutaneous stimulation at auricular concha
ear vagus nerve stimulator
Transcutaneous auricular non-vagal stimulation
Transcutaneous stimulation at auricular edge
ear vagus nerve stimulator
control
No transcutaneous stimulation is given
No interventions assigned to this group
Interventions
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ear vagus nerve stimulator
Eligibility Criteria
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Inclusion Criteria
* With age between 2-18 years old;
* The number and dose of the medication was kept constant no less than eight weeks before intervention;
* The patients or their guardians can count the frequency of the seizures and finish the study.
Exclusion Criteria
* Accompanied with progressive central nervous system diseases;
* Have severe heart, liver ,kidney or blood diseases;
* Be pregnant or having the schedule of pregnancy in the study period.
2 Years
18 Years
ALL
Yes
Sponsors
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Beijing Tiantan Hospital
OTHER
Beijing Children's Hospital
OTHER
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Wei He
Associate Professor
Principal Investigators
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Bing Zhu, Dr.
Role: STUDY_DIRECTOR
Institute of Acupuncture and Moxibustion, CACMS
Locations
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Wei He
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2011CB505201
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NSFC-81273829
Identifier Type: -
Identifier Source: org_study_id
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