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

Changping Laboratory

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: sham iTBS; Device: active iTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06031948

CPLASD2023HNC50

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 4 patient groups

DLPFC group

Experimental group

Description:

Active iTBS will be delivered to the left DLPFC.

Treatment:

Device: active iTBS

Device: active iTBS

DMPFC group

Experimental group

Description:

Active iTBS will be delivered to the left DMPFC.

Treatment:

Device: active iTBS

Device: active iTBS

Sham to DLPFC group

Sham Comparator group

Description:

Sham iTBS will be delivered to the left DLPFC.

Treatment:

Device: sham iTBS

Device: sham iTBS

Sham to DMPFC group

Sham Comparator group

Description:

Sham iTBS will be delivered to the left DMPFC.

Treatment:

Device: sham iTBS

Device: sham iTBS