Epilepsy
Conditions
Keywords
pediatric epilepsy, transcutaneous vagus nerve stimulation
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.
Interventions
DEVICEear vagus nerve stimulator
Sponsors
Beijing Tiantan Hospital
Beijing Children's Hospital
China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency of epileptic seizures | Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWei He, Dr.
Outcome results
None listed