pBFS Guided Precision Neuromodulation Treatment for ASD

Not Applicable

Recruiting

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

• Registration Number: NCT05735262
• Lead Sponsor: Changping Laboratory

Brief Summary

This study aims to evaluate the neuromodulation (i.e., iTBS) effectiveness for treating autism spectrum disorder (ASD) by targeting at the pBFS-guided executive function brain network or social brain network.

Detailed Description

Autism spectrum disorder is characterized by executive function deficiency and social interaction difficulty. Using the developed technique, personalized brain functional sectors (pBFS), we could precisely identify individualized brain function networks based on the resting-state functional MRI scan. A tailored dorsal lateral prefrontal cortex (DLPFC) region situated within the executive function network and a tailored dorsal medial prefrontal cortex (DMPFC) region situated within the social network will be selected as intervention targets.

The participants will be equally randomized to the following three groups, active iTBS to the left DLPFC, active iTBS to the left DMPFC, and sham iTBS to either the left DLPFC or left DMPFC at a ratio of 2:2:1:1. 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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-21
• Study Start: 2023-03-07
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30
• Primary Completion: 2024-03-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 6-30 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, 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 defects, 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 left DLPFC.
DMPFC group	active iTBS	Active iTBS will be delivered to the left DMPFC.
Sham to DMPFC group	sham iTBS	Sham iTBS will be delivered to 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

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
CBCL score change	Pre-treatment (baseline), immediately post-treatment	Score change of the child behavior checklist (CBCL) from baseline

Trial Locations

Locations (1)

China Rehabilitation Research Center; 🇨🇳 Beijing, China