Autism Spectrum Disorde
Conditions
Interventions
Single-arm experiment:Treatment with ultra-low-dose bremsstrahlung radiation generated by phosphorus-32
Sponsors
Sunshine Union Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Age between 3 and 15 years old, regardless of gender. 2. Meet the diagnostic criteria for Autism Spectrum Disorder (ASD) in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and the diagnosis is independently confirmed by two senior child psychiatrists. 3. The condition has been relatively stable for at least 3 months before enrollment, and the subject has not received other experimental interventions. 4. The legal guardian of the subject fully understands this study, voluntarily participates and signs a written informed consent form. 5. The subject (with the assistance of the guardian) can cooperate with wearing the head patch device and complete 1-hour treatment each time. 6. The guardian agrees to avoid letting the subject start any new therapies that may affect central nervous system function (such as new behavioral interventions, transcranial magnetic stimulation, etc.) during the study, and promises to truthfully record all concomitant medications and treatments.
Exclusion criteria
Exclusion criteria: 1. Suffering from other definite organic diseases of the central nervous system (such as epilepsy, cerebral palsy, etc.) other than ASD; 2. Having severe and unstable comorbid psychiatric disorders (such as severe depression, bipolar disorder, schizophrenia, etc.), or having significant self-harm/aggressive behaviors that require emergency intervention; 3. Having used drugs that may significantly affect the central nervous system (such as antipsychotics, anticonvulsants, central stimulants, etc.) or received a new systematic behavioral intervention program within 4 weeks before enrollment; 4. Having a history of craniocerebral surgery or radiotherapy in the past, or being known to be highly sensitive to ionizing radiation; 5. Being allergic to P32; 6. Having active infections, lesions, dermatitis, psoriasis or other skin diseases in the treatment target area (skin of the frontal, parietal, temporal and occipital regions); 7. Having severe and uncontrolled physical diseases (such as heart, liver and kidney failure, blood system diseases, immunodeficiency diseases, malignant tumors, etc.); 8. Currently participating in or planning to participate in any other interventional clinical trials; 9. Being judged by the researcher that the family cannot cooperate to complete all the treatments and the 6-12-month follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Autism Behavior Scale Score;Childhood Autism Rating Scale Score;PET/MR brain metabolism; | — |
Secondary
| Measure | Time frame |
|---|---|
| micronucleus test;Chromosomal aberration;oxytocin;Blood routine test; | — |
Countries
China
Contacts
Public ContactSu fuyong
Sunshine Union Hospital
Outcome results
None listed