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

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Device: active iTBS; Device: sham iTBS

• Registration Number: NCT06031948
• Lead Sponsor: Changping Laboratory

Brief 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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Last Update Submitted: 2023-09-04
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Study Start: 2023-10-01
• Primary Completion: 2024-08-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 2.5-6 years old
• Have the diagnosis of autism spectrum disorder
• ADOS-2 score is higher than the ASD cut-offs
• Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
• Participant's parents or other legal guardians give informed consent

Exclusion Criteria

• Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
• Severe self-injury or suicidal behavior presented in the last 1 year
• Severe visual, auditory, or motor disability that interferes with any study procedure
• Current, history or family history of epilepsy
• Known severe physical diseases, such as congenital heart defect, traumatic brain injury
• Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
• Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
• Currently participating in other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DLPFC group	active iTBS	Active iTBS will be delivered to the left DLPFC.
Sham to DLPFC group	sham iTBS	Sham iTBS will be delivered to the left DLPFC.
Sham to DMPFC group	sham iTBS	Sham iTBS will be delivered to the left DMPFC.
DMPFC group	active iTBS	Active iTBS will be delivered to the left DMPFC.

Primary Outcome Measures

Name	Time	Method
ADOS-2 SA change	Pre-treatment (baseline), immediately post-treatment	The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
ADOS-2 total score change	Pre-treatment (baseline), immediately post-treatment	The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
CBCL score change	Pre-treatment (baseline), immediately post-treatment	Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.