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pBFS Guided aiTBS Over Language Network for ASD Child
Sponsor: Beijing Changping Tianhe Research Institute of Brain Science
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 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.
Official title: Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Language Deficit Comorbid in Autism Spectrum Disorder Child: a Multi-center, Randomized, Sham-controlled Trial
Key Details
Gender
All
Age Range
3 Years - 6 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-04-25
Completion Date
2027-06-01
Last Updated
2025-05-11
Healthy Volunteers
No
Conditions
Interventions
active iTBS
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.
Sham iTBS
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
Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.
Locations (1)
Peking University Sixth Hospital
Beijing, China