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RECRUITING
NCT06950437
NA

pBFS Guided aiTBS Over Language Network for ASD Child

Sponsor: Beijing Changping Tianhe Research Institute of Brain Science

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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.

BEHAVIORAL

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