← Back to Clinical Trials
Recruiting NCT06950437

pBFS Guided aiTBS Over Language Network for ASD Child

Trial Parameters

Condition Autism Spectrum Disorder
Sponsor Beijing Changping Tianhe Research Institute of Brain Science
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 3 Years
Max Age 6 Years
Start Date 2025-04-25
Completion 2026-12-31
Interventions
active iTBSSham iTBSspeech therapy

Brief Summary

The aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (ASD) who also have language development delay. The neuromodulation will be delivered using the accelerated intermittent theta burst stimulation (aiTBS) protocol, targeting the language network in the left superior frontal gyrus (SFG), guided by personalized Brain Functional Sector (pBFS) technology.

Eligibility Criteria

Inclusion Criteria: 1. Professionally diagnosed with ASD per DSM - 5 criteria. 2. Aged 3 - 6.5 years, either gender. 3. ADOS-2 results meet ASD standard cut - off. 4. SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age \< 4 years). 5. Co-existing language disorder not explaining ASD symptoms. No organic speech organ lesions. CNBS-R2016 and CLAS-TP language-related equivalent age \> 18 months; any CLAS-TP dimension score \< 6. 6. Mandarin is the daily communication language. 7. May have intellectual/global developmental delay not explaining ASD symptoms. 8. Guardians volunteer, can cooperate in treatment and sign informed consent. Exclusion Criteria: 1. Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.). 2. Serious self-harm in the past year. 3. Severe sensory/motor disorders precluding cooperation. 4. History of epileptic seizures. 5. Serious organic diseases, especially brain related. 6. Contraindications for MRI/TMS (metal/implants). 7. Resp

Related Trials