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pBFS Guided aiTBS Over Language Network for ASD Child

RecruitingNAAges 3 Years - 6 YearsAllBeijing Changping Tianhe Research Institute of Br…
NCT06950437 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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. Respiratory/circulatory diseases with sedation risk. 8. Illiterate guardians unable to handle informed consent/questionnaires. 9. Received neuromodulation in the past 3 months. 10. Currently in other clinical trials. 11. Deemed unfit by the researcher.
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What it tests

  • active iTBS
  • Sham iTBS
  • speech therapy
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Where

1 site
Peking University Sixth Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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