Status:
RECRUITING
pBFS Guided aiTBS Over Language Network for ASD Child
Lead Sponsor:
Beijing Changping Tianhe Research Institute of Brain Science
Collaborating Sponsors:
Peking University Sixth Hospital
Shanghai Yangzhi Rehabilitation Hospital
Conditions:
Autism Spectrum Disorder
Language Delay
Eligibility:
All Genders
3-6 years
Phase:
NA
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 developme...
Detailed Description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder often accompanied by language delay. Emerging evidence indicates that Transcranial Magnetic Stimulation (TMS) has been effective in rest...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06950437
Start Date
April 25 2025
End Date
June 1 2027
Last Update
May 11 2025
Active Locations (1)
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1
Peking University Sixth Hospital
Beijing, China