Childhood autism spectrum disorder
Conditions
Interventions
Group 1:Treatment was performed using a therapeutic device with a dose of 1 µSv/h.
Group 2:Treatment was performed using a therapeutic device with a dose of 2 µSv/h.
Group 3:Treatment was performed using a therapeutic device with a dose of 4 µSv/h.
Group 4:Treatment was performed using a therapeutic device with a dose of 6 µSv/h.
Group 5:Treatment was performed using a therapeutic device with a dose of 8 µSv/h.
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
3 Years to 15 Years
Inclusion criteria
Inclusion criteria: (1) Age 3-15 years, gender not limited. (2) Meets the diagnostic criteria for Autism Spectrum Disorder (ASD) in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), and independently confirmed by two senior child psychiatrists. (3) The condition has been relatively stable for at least 3 months prior to enrollment, and the participant has not received any other experimental interventions. (4) The participant's legal guardian fully understands this study, voluntarily participates, and signs a written informed consent form. (5) The participant (with the assistance of their guardian) is able to cooperate in wearing the head patch and complete each 1-hour treatment session. (6) The guardian agrees to avoid initiating any new therapies that may affect the central nervous system function (such as new behavioral interventions, transcranial magnetic stimulation, etc.) during the study period and promises to accurately record all concomitant medications and treatments.
Exclusion criteria
Exclusion criteria: (1) Suffering from other identifiable organic diseases of the central nervous system besides ASD (e.g., epilepsy, cerebral palsy). (2) Having severe, unstable psychiatric comorbidities (e.g., major depressive disorder, bipolar disorder, schizophrenia), or exhibiting significant self-harm/aggressive behavior requiring urgent intervention. (3) Having used medications that may significantly affect the central nervous system (e.g., antipsychotics, anticonvulsants, central nervous system stimulants) or undergone a new systematic behavioral intervention program within 4 weeks prior to enrollment. (4) Having a history of craniocerebral surgery or radiotherapy, or being known to be highly sensitive to ionizing radiation. (5) Being allergic to 32P. (6) Having active infections, lesions, dermatitis, or psoriasis in the treatment target area (forehead, parietal, temporal, and occipital skin). (7) Having severe, uncontrolled physical illnesses (e.g., heart, liver, or kidney failure, hematological diseases, immunodeficiency diseases, malignant tumors). (8) Currently participating in or planning to participate in any other interventional clinical trials. (9) Individuals whose family is deemed unable to cooperate in completing the full treatment and 6-12 month follow-up by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine examination;Adverse reactions; | — |
Countries
China
Contacts
Public ContactLiu Yulong
The Second Affiliated Hospital of Soochow University
Outcome results
None listed