global developmental delay in children
Conditions
Interventions
Group A:transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS)
Group B:sham-tVNS
Sponsors
The Third Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. meet the diagnostic criteria for GDD in DSM-V; 2. aged 1-5 years old; 3. DQ is between 25 and 75 and the social life ability scale for children from the infants to middle school students is less than or equal to 8; 4. vagus nerve stimulation treatment has not been applied in the past 3 months; 5. Informed consent form has been signed by parents of the children with GDD.
Exclusion criteria
Exclusion criteria: 1. Patients with implanted medical devices such as pacemakers; 2. Patients with acute disease, infectious disease, malignant tumor, or heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gesell Development Schedule Test;Infants to Junior High School Students social life scale (S-M scale);Chinese children's emotional and social development scale (CITSEA) /Achenbach Child Behavior Checklist (CBCL); | — |
Secondary
| Measure | Time frame |
|---|---|
| electrocardiogram;TNF-a, IL-6, IL-1ß, IL-10 in peripheral blood; | — |
Countries
China
Contacts
Public ContactZhang Guangyu
The Third Affiliated Hospital of Zhengzhou University
Outcome results
None listed