An interventional study of active iTBS and Sham iTBS in Autism Spectrum Disorder and Language Delay, sponsored by Beijing Changping Tianhe Research Institute of Brain Science. Recruiting at 1 site in China. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Beijing Changping Tianhe Research Institute of Brain Science · Not applicable, Interventional, and Treatment
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.
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 restoring language ability in post-stroke aphasia, but its efficacy in developmental language disorders remains unknown.
By leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can accurately locate the individual language function brain network. Considering the accessibility and comfort of neuromodulation, we will stimulate the language network node in the superior frontal gyrus (SFG) for 12 weeks.
In this study, participants meeting the inclusion and exclusion criteria will be randomly assigned to either the active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol lasts for 12 weeks, with sessions held 5 days a week and 3 iTBS sessions over the SFG per day. The inter-session interval is set at 50 minutes, along with speech therapy. Clinical evaluations focusing on language and ASD symptoms will be conducted at baseline, after the 12-week treatment period, and at 24-week follow-up after the start of treatment.
Exclusion Criteria:
active iTBS over SFG
Device: active iTBS · Behavioral: speech therapy
sham iTBS over SFG
Device: Sham iTBS · Behavioral: speech therapy
Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique.
Participants will undergo three sham iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique.
Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.
CLAS-TP score change after treatment
The score changes of combined CLAS-TP (Child Language Assessment Scale - Test for Preschoolers) score at 12-week from baseline. Higher scores mean a better outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week)
CLAS-TP total score change from baseline to follow-up
Higher scores mean a better outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
CLAS-TP subscale score change from baseline to follow-up
For the story comprehension subscale, only participants who had non-zero point were included. Higher scores mean a better outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
WPPSI language score change from baseline to follow-up
Higher scores mean a better outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
ADOS-2 SA score change from baseline to follow-up
Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
SCQ score change from baseline to follow-up
Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
ATEC score change from baseline to follow-up
Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
CBCL score change from baseline to follow-up
Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
QoL score change from baseline to follow-up
Higher scores mean a better outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
Plan to share: Undecided
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Language Development Disorders→