Back to resultsTranscutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy
Primary Purpose
Epilepsy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ear vagus nerve stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring pediatric epilepsy, transcutaneous vagus nerve stimulation
Eligibility 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.
Sites / Locations
- Wei HeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
No Intervention
Arm Label
Transcutaneous auricular vagal stimulation
Transcutaneous auricular non-vagal stimulation
control
Arm Description
Transcutaneous stimulation at auricular concha
Transcutaneous stimulation at auricular edge
No transcutaneous stimulation is given
Outcomes
Primary Outcome Measures
frequency of epileptic seizures
Secondary Outcome Measures
Number of participants with adverse events as a measure of safety and tolerability
Full Information
NCT ID
NCT02004340
First Posted
November 13, 2013
Last Updated
February 12, 2015
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Beijing Tiantan Hospital, Beijing Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02004340
Brief Title
Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Beijing Tiantan Hospital, Beijing Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
pediatric epilepsy, transcutaneous vagus nerve stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous auricular vagal stimulation
Arm Type
Active Comparator
Arm Description
Transcutaneous stimulation at auricular concha
Arm Title
Transcutaneous auricular non-vagal stimulation
Arm Type
Sham Comparator
Arm Description
Transcutaneous stimulation at auricular edge
Arm Title
control
Arm Type
No Intervention
Arm Description
No transcutaneous stimulation is given
Intervention Type
Device
Intervention Name(s)
ear vagus nerve stimulator
Primary Outcome Measure Information:
Title
frequency of epileptic seizures
Time Frame
Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures
Secondary Outcome Measure Information:
Title
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"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei He, Dr.
Phone
86 10 64089403
Email
hazel7811@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Zhu, Dr.
Organizational Affiliation
Institute of Acupuncture and Moxibustion, CACMS
Official's Role
Study Director
Facility Information:
Facility Name
Wei He
City
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei He, Dr.
Phone
86 10 64089403
Email
hazel7811@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26292720
Citation
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.
Results Reference
derived
Learn more about this trial
Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy
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