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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 150 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →This is the only study on the registry with Beijing Changping Tianhe Research Institute of Brain Science as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 20 months is below that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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