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pBFS Guided rTMS Over Cognitive Control Network for ASD
Sponsor: Changping Laboratory
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
Conditions
Interventions
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.
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