Autism Spectrum Disorder
Conditions
Interventions
Experimental group:transcranial temporal interference stimulation
Sponsors
The First Medical Center of the Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The participant and their legal guardian understand and are willing to participate in this trial, and the legal guardian signs the informed consent form. 2.? Aged 6-12 years (inclusive of 6 years old, based on the date of signing the informed consent form, and age <12 years during the treatment period), regardless of gender. 3.? Meets the diagnostic criteria for Autism Spectrum Disorder (ASD) as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5); meets the ASD diagnostic criteria of the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2); and has a Wechsler Intelligence Scale for Children (WISC) score <=70. 4.? The patient has stable caregiving conditions, with the same guardian responsible throughout the study period. It is expected that environmental factors such as residence and living conditions will remain as consistent as possible during the study.
Exclusion criteria
Exclusion criteria: 1.? Individuals with metal implants in the body: including metallic materials (including MRI-compatible materials like titanium), arterial clips, etc.; or those with implanted devices such as: pacemakers or defibrillators, deep brain stimulators, drug pumps, cochlear implants, orthodontic appliances, etc.; 2.? Patients with intracranial hypertension, skull defects, those in the acute phase of traumatic brain injury or with unstable intracranial infections, or in the acute phase of cerebrovascular disease; 3.? Individuals with malignant tumors or severe autoimmune diseases in an active phase; 4.? Patients with severe dysfunction of vital organs (heart, lungs, liver, kidneys, etc.) or unstable vital signs; 5.? Presence of active skin lesions or inflammation at the site of electrode contact, such as: herpes, acne, eczema, dermatitis, psoriasis, shingles, etc.; 6.? Other mental disorders not attributable to Autism Spectrum Disorder, such as those caused by active epilepsy, cerebrovascular disease, or brain trauma; 7.? Other patients deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social Responsiveness Scale Score; Vineland Adaptive Behavior Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cranial magnetic resonance imaging;Swanson, Nolan, and Pelham-IV (SNAP-IV) Rating Scale Score;Child Behavior Checklist scale Score;Repetitive Behavior Scale-Revised scale Score;Screen for Child Anxiety Related Emotional Disorders - Parent Version scale;Autism Treatment Evaluation Checklist scale Score;EEG examination;Eye tracking;Video recordings of behavioral performance; | — |
Countries
China
Contacts
Public ContactYang Guang
The First Medical Center of the Chinese PLA General Hospital
Outcome results
None listed