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Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

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ClinicalTrials.gov Identifier: NCT02004340
Recruitment Status : Unknown
Verified February 2015 by Wei He, China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : February 13, 2015
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Beijing Children's Hospital
Information provided by (Responsible Party):
Wei He, China Academy of Chinese Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epilepsy Device: ear vagus nerve stimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy
Study Start Date : November 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Active Comparator: Transcutaneous auricular vagal stimulation
Transcutaneous stimulation at auricular concha
Device: ear vagus nerve stimulator
Sham Comparator: Transcutaneous auricular non-vagal stimulation
Transcutaneous stimulation at auricular edge
Device: ear vagus nerve stimulator
No Intervention: control
No transcutaneous stimulation is given



Primary Outcome Measures :
  1. frequency of epileptic seizures [ Time Frame: Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures ]

Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks" ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed as epilepsy;
  • 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:

  • The patient is receiving the VNS therapy;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004340


Contacts
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Contact: Wei He, Dr. 86 10 64089403 hazel7811@hotmail.com

Locations
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China
Wei He Recruiting
Beijing, China, 100700
Contact: Wei He, Dr.    86 10 64089403    hazel7811@hotmail.com   
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Beijing Tiantan Hospital
Beijing Children's Hospital
Investigators
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Study Director: Bing Zhu, Dr. Institute of Acupuncture and Moxibustion, CACMS

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wei He, Associate Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02004340     History of Changes
Other Study ID Numbers: NSFC-81273829
2011CB505201 ( Other Grant/Funding Number: National Basic Resaearch Program (973 Program) )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015
Keywords provided by Wei He, China Academy of Chinese Medical Sciences:
pediatric epilepsy
transcutaneous vagus nerve stimulation
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases