[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639007":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":47,"collaborators":25,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":25,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":25,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":25,"overallStatus":29,"whyStopped":25,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group (tTIS)","EXPERIMENTAL","Receive tTIS targeting the anterior middle temporal gyrus, with stimulation frequency of 2040\u002F2000HZ, using battery power supply: voltage 12V, current set at 1.5mA, 6 times\u002Fday, 20min\u002Fsession with 20min intervals between sessions, lasting for 5 days",[13],"Device: transcranial Temporal Interference Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","Receive tTIS targeting the anterior middle temporal gyrus, with stimulation frequency of 2000\u002F2000HZ(without 40Hz envelope compared to tTIS group), using battery power supply: voltage 12V, current set at 1.5mA, 6 times\u002Fday, 20min\u002Fsession with 20min intervals between sessions, lasting for 5 days",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","transcranial Temporal Interference Stimulation","Receive tTIS targeting the anterior middle temporal gyrus with stimulation frequency of 2040\u002F2000HZ, using battery power supply: voltage 12V, current set at 1.5mA, 6 times\u002Fday, 20min\u002Fsession with 20min intervals between sessions, lasting for 5 days.",[15,9],null,[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Fei Li","RECRUITING","Shanghai","Shanghai Municipality","200092","China","CN",{"type":36,"coordinates":37},"Point",[38,39],121.45806,31.22222,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":25,"email":46},"Fei Li, PHD, MD","CONTACT","+86-21-25077461","feili@shsmu.edu.cn",{"type":48,"investigatorFullName":28,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Chief Physician","100639007","transcranial-temporal-interference-stimulation-for-children-with-autism-spectrum-disorders-100639007",false,"NCT07625748","Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders","Individualized Targeted Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorder: A Single-Blinded, Randomized, Controlled Exploratory Trial","Inclusion Criteria:\n\n* Children aged 4-10 years\n* Meeting the diagnostic criteria for ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and confirmed by the Autism Diagnostic Observation Schedule (ADOS) and\u002For the Autism Diagnostic Interview-Revised (ADI-R)\n* Full Scale Intelligence Quotient (FSIQ) ≥50\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Individuals with metal implants in the body\n* Individuals with neurological disorders such as epilepsy\n* Those requiring surgical treatment due to structural abnormalities indicated by brain MRI examination\n* Those diagnosed with genetic or chromosomal abnormalities\n* Individuals with mental illness (such as early-onset schizophrenia)\n* Those with severe cardiac disease\n* Individuals with increased intracranial pressure\n* Those currently participating in other clinical trials\n* Those who received new intervention protocols within 4 weeks prior to enrollment.","ALL","4 Years","10 Years",{"count":61,"type":62},16,"ESTIMATED","INTERVENTIONAL",[65],"NA","The goal of this single-blinded, randomized controlled trial is to assess the safety, tolerability, and feasibility of tTIS for children with ASD. The main question it aims to answer is:\n\n\\- Is tTIS safe, tolerable, and feasible for use for children with autism spectrum disorder?\n\nResearchers will compare tTIS group with control group to explore the safety and feasibility of the transcranial electrical stimulation for children with autism.\n\nParticipants will:\n\n* tTIS group: undergo 5 days of temporal tTIS.\n* Sham group: undergo 5 days of temporal tTIS without low-frequency envelope.\n\nFrom baseline to 4 weeks after intervention completion, subjects will be followed up regarding clinical symptoms and adverse events:\n\n* Primary Outcome Measures: Safety and feasibility of tTIS, assessed by adverse events, treatment completion rate, adherence to the stimulation protocol and tolerability.\n* Secondary\u002FExploratory Outcome Measures: Changes in SRS-2 total scores and other clinical measures related to language, adaptive functioning, and cognition.",[68],"Autism Spectrum Disorder","2026-05-29",{"date":71,"type":72},"2026-06-04","ACTUAL",{"date":74,"type":62},"2026-05-25",{"date":76,"type":62},"2026-10-05",{"name":5,"class":6},1]