pBFS Guided Precision Neuromodulation Treatment for ASD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Personalized Brain Functional Sectors (pBFS) Guided Precision Neuromodulation Treatment for Autism Spectrum Disorder (ASD): a Single-center, Sham-controlled, Double-blinded, Randomized Clinical Trial Study

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: active iTBS
* Device: sham iTBS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DLPFC group<br>Active iTBS will be delivered to the left DLPFC. | Device: active iTBS<br>* Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.<br>|
| Experimental: DMPFC group<br>Active iTBS will be delivered to the left DMPFC. | Device: active iTBS<br>* Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.<br>|
| Sham Comparator: Sham to DLPFC group<br>Sham iTBS will be delivered to left DLPFC. | Device: sham iTBS<br>* Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.<br>|
| Sham Comparator: Sham to DMPFC group<br>Sham iTBS will be delivered to left DMPFC. | Device: sham iTBS<br>* Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADOS-2 SA change | The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline | Pre-treatment (baseline), immediately post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADOS-2 total score change | The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline | Pre-treatment (baseline), immediately post-treatment | 
| CBCL score change | Score change of the child behavior checklist (CBCL) from baseline | Pre-treatment (baseline), immediately post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, fMRI, ASD, personalized