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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Changping Laboratory
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- ADOS-2 SA change
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
ADOS-2 SA change
Time Frame: 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 Outcomes
- ADOS-2 total score change(Pre-treatment (baseline), immediately post-treatment)
- CBCL score change(Pre-treatment (baseline), immediately post-treatment)