Actively Recruiting
pBFS Guided aiTBS Over Language Network for ASD Child
Led by Beijing Changping Tianhe Research Institute of Brain Science · Updated on 2025-05-11
150
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
B
Beijing Changping Tianhe Research Institute of Brain Science
Lead Sponsor
P
Peking University Sixth Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
pBFS Guided aiTBS Over Language Network for ASD Child
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Professionally diagnosed with autism spectrum disorder (ASD) according to DSM-5 criteria
- Age between 3 and 6.5 years, any gender
- Meets ASD standard cut-off on ADOS-2 test
- SCQ score of 15 or higher if age 4 years or older, or 11 or higher if younger than 4 years
- Has a co-existing language disorder not explaining ASD symptoms; no organic speech organ lesions
- CNBS-R2016 and CLAS-TP language-related equivalent age greater than 18 months; any CLAS-TP dimension score less than 6
- Mandarin is the daily communication language
- May have intellectual or global developmental delay not explaining ASD symptoms
- Guardians volunteer, can cooperate with treatment, and sign informed consent
You will not qualify if you...
- Identified genetic pathogenic factors or current/past comorbid severe disorders like ADHD or Tourette's
- Serious self-harm within the past year
- Severe sensory or motor disorders that prevent cooperation
- History of epileptic seizures
- Serious organic diseases, especially brain-related
- Contraindications for MRI or TMS such as metal implants
- Respiratory or circulatory diseases posing sedation risk
- Guardians unable to read or handle informed consent and questionnaires
- Received neuromodulation treatment in the previous 3 months
- Currently participating in other clinical trials
- Considered unfit for the study by the researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Sixth Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xinyu Duan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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