pBFS Guided Precision Neuromodulation Treatment for ASD

Changping Laboratory

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: active iTBS; Device: sham iTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT05735262

CPASD2023BA100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups

DLPFC group

Experimental group

Description:

Active iTBS will be delivered to the left DLPFC.

Treatment:

Device: active iTBS

DMPFC group

Experimental group

Description:

Active iTBS will be delivered to the left DMPFC.

Treatment:

Device: active iTBS

Sham to DLPFC group

Sham Comparator group

Description:

Sham iTBS will be delivered to left DLPFC.

Treatment:

Device: sham iTBS

Sham to DMPFC group

Sham Comparator group

Description:

Sham iTBS will be delivered to left DMPFC.

Treatment:

Device: sham iTBS