Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Epilepsy

Treatments: Device: ear vagus nerve stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02004340

2011CB505201 (Other Grant/Funding Number)

NSFC-81273829

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Transcutaneous auricular vagal stimulation

Active Comparator group

Description:

Transcutaneous stimulation at auricular concha

Treatment:

Device: ear vagus nerve stimulator

Transcutaneous auricular non-vagal stimulation

Sham Comparator group

Description:

Transcutaneous stimulation at auricular edge

Treatment:

Device: ear vagus nerve stimulator

control

No Intervention group

Description:

No transcutaneous stimulation is given