pBFS Guided aiTBS Over Language Network for ASD Child

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Autism Spectrum Disorder, Language Delay

In brief

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.

Key facts

Study ID

NCT06950437

Run by

Beijing Changping Tianhe Research Institute of Brain Science

People needed

150

Starts

2025-04-25

Expected to finish

2027-06-01

Last updated by the study team

2025-05-11

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Professionally diagnosed with ASD per DSM - 5 criteria.
• Aged 3 - 6.5 years, either gender.
• ADOS-2 results meet ASD standard cut - off.
• SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age < 4 years).
• 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.
• Mandarin is the daily communication language.
• May have intellectual/global developmental delay not explaining ASD symptoms.
• Guardians volunteer, can cooperate in treatment and sign informed consent.

You may not qualify if…

• Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.).
• Serious self-harm in the past year.
• Severe sensory/motor disorders precluding cooperation.
• History of epileptic seizures.
• Serious organic diseases, especially brain related.
• Contraindications for MRI/TMS (metal/implants).
• Respiratory/circulatory diseases with sedation risk.
• Illiterate guardians unable to handle informed consent/questionnaires.
• Received neuromodulation in the past 3 months.
• Currently in other clinical trials.
• Deemed unfit by the researcher.

Where it is running

• Peking University Sixth Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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