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RECRUITING
NCT06255535
NA

pBFS Guided rTMS Over Cognitive Control Network for ASD

Sponsor: Changping Laboratory

View on ClinicalTrials.gov

Summary

The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. The neuromodulation will be administered using intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC), guided by personalized Brain Functional Sector (pBFS) technology.

Official title: Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial

Key Details

Gender

All

Age Range

6 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

215

Start Date

2024-04-01

Completion Date

2026-12-01

Last Updated

2025-02-21

Healthy Volunteers

No

Interventions

DEVICE

active iTBS treatment

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 treatment

Participants will undergo three 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.

Locations (6)

Fujian Children's Hospital

Fuzhou, Fujian, China

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, China

Hebei Provincial Mental Health Center

Baoding, Hebei, China

Xi'an TCM Hospital of Encephalopathy

Xi'an, Shaanxi, China

Jining Medical University

Jining, Shandong, China

Linyi Hedong Rehabilitation Hospital

Linyi, Shandong, China