Global developmental delay
Conditions
Interventions
Group 1 (taVNS Group):For taVNS treatment, the ear electrodes and the child’s ear are first cleaned with a warm, moist towel or conductive gel. The TVNS-100 transauricular vagus nerve stimulator is th
Group 2 (Sham Stimulation Group):For the sham taVNS treatment, the concha electrode is placed snugly against the skin of the ear concha, and the ear canal electrode is secured at the entrance of the e
Sponsors
The Third Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
2 Years to 5 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria (All of the following must be met): 1. Meets the diagnostic criteria for Global Developmental Delay (GDD) as defined in the *Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)*; 2. Scores on at least two domains (including the adaptive domain) of the Gesell Developmental Scales–Chinese Revised Version must be >=25 and <75; 3. Age between 2 and 5 years; 4. No use of vasoactive medications (e.g., calcium channel blockers, nitrates, etc.) within the past month prior to enrollment to avoid interference of drug effects on cerebral hemodynamic signals; 5. Written informed consent provided by the legal guardian after thorough understanding of the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (Any of the following applies): 1. Presence of skull defects or unhealed wounds on the head; 2. History of severe cerebrovascular disease; 3. Any other severe physical or mental disorders that may cause cerebral dysfunction; 4. Presence of epilepsy; 5. Severe fussing, excessive head movement, or inability to cooperate during the testing process.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gesell Developmental Schedules;Multichannel near-infrared functional brain imaging; | — |
Countries
China
Contacts
Public ContactDengna Zhu
The Third Affiliated Hospital of Zhengzhou University
Outcome results
None listed