Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

February 12, 2015 updated by: Wei He, China Academy of Chinese Medical Sciences

Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frequency of epileptic seizures
Time Frame: Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures
Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures

Secondary Outcome Measures

Outcome Measure
Time Frame
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"
participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Academy of Chinese Medical Sciences

Collaborators

Beijing Tiantan Hospital
Beijing Children's Hospital

Investigators

  • Study Director: Bing Zhu, Dr., Institute of Acupuncture and Moxibustion, CACMS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSFC-81273829
  • 2011CB505201 (Other Grant/Funding Number: National Basic Resaearch Program (973 Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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