Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02004340
• Other study ID #: NSFC-81273829
• Secondary ID: 2011CB505201
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2013
• Last updated: February 12, 2015
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2015
• Source: China Academy of Chinese Medical Sciences
• Contact: Wei He, Dr.
• Phone: 86 10 64089403
• Email: hazel7811[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• ear vagus nerve stimulator

Locations

Country	Name	City	State
China	Wei He	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Beijing Children's Hospital, Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of epileptic seizures		Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures	No
Secondary	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"	Yes