Global developmental delay
Conditions
Interventions
Sham stimulation group:Standard rehabilitation therapy+Temporal Interference Sham Stimulation (No actual current)
Sponsors
The Third Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
2 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Age: 24 to 60 months; 2. Meets DSM-5 diagnostic criteria for global developmental delay; 3. Gesell Developmental Scale assessment: Scores below 75 in two or more domains, including the adaptive skills domain; 4. Able to reliably describe pain, fear, or discomfort; 5. Parent or guardian consents to study participation, completes pre-treatment evaluations, and signs informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with motor disorders such as cerebral palsy or spinal cord injury; 2. Patients with severe hearing or visual impairments, or other conditions affecting assessment; 3. Those with epilepsy or other severe neurological disorders; 4 Patients with identifiable causes of developmental delay, such as postnatal encephalitis, traumatic brain injury, cerebral hemorrhage, or confirmed diagnoses of genetic metabolic disorders or neurodegenerative diseases; 5. Patients with cardiac pacemakers or other electronic implants; 6. Patients with metallic implants or intracranial metal fragments; 7. Patients who have recently undergone other brain stimulation therapies; 8. Patients with allergies or contraindications to electrical stimulation therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gesell Developmental Scale ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electroencephalogram assessment;fNIRS ; | — |
Countries
China
Contacts
Public ContactDengna Zhu
The Third Affiliated Hospital of Zhengzhou University
Outcome results
None listed