NCT07515261

pBFS Guided Neuromodulation Over DMPFC for ASD Treatment: Pilot Study

Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Comorbid Autism Spectrum Disorder and Language Delay: an One-arm Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 6 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the feasibility and preliminary efficacy of pBFS-guided TMS treatment at DMPFC in autism spectrum disorder comorbid with language delay.

Detailed description

Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors, often co-occurring with language delay. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying language and social communication a based on the resting-state functional MRI data. The tailored TMS intervention target to language and default mode network which located in the left dorsal medial prefrontal cortex (DMPFC) will be selected for each participant. The participants will receive active iTBS to the language network 5 days per week for 12 weeks. Functional MRI data will be collected pre-and post-treatment under sedation. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.

Conditions

• Autism Spectrum Disorder With Language Delay

Interventions

Type	Name	Description
DEVICE	active iTBS	Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

Timeline

• Start date: 2023-03-10
• Primary completion: 2024-02-27
• Completion: 2024-05-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: China