NCT06031948

pBFS-guided Noninvasive Neuromodulation for Pre-school Children With ASD

Personalized Brain Functional Sectors (pBFS) Guided Noninvasive Neuromodulation Treatment for Pre-school Children With Autism Spectrum Disorder (ASD): a Single-center, Double-blinded, Sham-Controlled, Randomized Clinical Trial Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 30 Months – 6 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD).

Detailed description

Autism spectrum disorder is a neurodevelopmental disorder, begins early in life. Using the personalized brain functional sectors (pBFS) technology, investigators could precisely identify individualized brain function networks based on the functional MRI scan. For each participant, two personalised TMS intervention targets will be chosen by blinded researcher. One executive function network target is located in the dorsal lateral prefrontal cortex (DLPFC) , and the other social function network target is located in the dorsal medial prefrontal cortex (DMPFC). The participants will be equally randomized to the following four groups, active iTBS to the left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio of 2:2:1:1. Later analyses will combine the two sham groups as one control group. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions. Pre-and post-treatment functional MRI data will be collected under sedation.

Conditions

• Autism Spectrum Disorder

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

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-08-01
• Completion: 2025-01-01
• First posted: 2023-09-11
• Last updated: 2023-09-11