Autism Spectrum Disorder
Conditions
Interventions
VNS:None
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Children aged 3–18 years who meet the diagnostic criteria for Autism Spectrum Disorder (ASD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 2. Subjects or their guardians are able to fully understand the therapy and provide signed informed consent; 3. Subjects or their family members are capable of cooperating with relevant scale assessment tests; 4. Subjects who have received formal and stable doses of psychiatric medication for at least 6 months prior to enrollment without efficacy and agree not to initiate new or modify existing medication or behavioral interventions.
Exclusion criteria
Exclusion criteria: 1) Implantation of active implantable medical devices (such as pacemakers, implantable hearing aids, etc.) or metal devices, such as stents, bone plates, or bone screws. 2) Comorbid physical or mental illnesses that may impair the ability to tolerate vagus nerve stimulation or comply with study requirements (e.g., insulin-dependent diabetes mellitus, bipolar disorder, etc.). 3) Vagus nerve lesions, injuries, or structural abnormalities (such as lymphadenopathy, tumors, or previous surgeries) or pain. 4) Current or past history of neurological diseases or trauma, including uncontrolled epilepsy and head injuries. 5) Current or recent (within 12 months) participation in clinical trials of drugs or medical devices. 6) Use of drugs affecting the autonomic nervous system (ß-blockers, ß-stimulants, etc.) within 4 weeks. 7) Use of cannabis (including medical cannabis) for any indication. 8) Specific allergic constitution that cannot tolerate foreign body implantation. 9) Poor general physical condition that cannot tolerate surgery, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Autism behavior checklist,ABC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Child autism rating scale,CARS;Autism diagnostic observation schedule;The Wechsler Intelligence Scale for Children, WISC; | — |
Countries
China
Contacts
Public ContactTInghong Liu
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed