Global developmental delay
Conditions
Interventions
Sham stimulation group:Standard rehabilitation therapy+Temporal Interference 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 diagnostic criteria for pervasive developmental delay as outlined in DSM-5; (3) GDS developmental assessment: Scores below 75 in two or more domains, including the adaptive functioning domain; (4) Parent or guardian consents to study participation, completes pre-treatment examinations, 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 impairment, or other conditions affecting assessment; (3) Those with epilepsy or other serious neurological disorders; (4) Patients with identifiable causes of developmental delay, such as postnatal encephalitis, traumatic brain injury, cerebral haemorrhage, 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 metallic fragments; (7) Recent receipt of other brain stimulation therapies; (8) Hypersensitivity 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