Precision TMS Treatment Guided by Personalized Brain Functional Sectors (pBFS) for ASD

Changping Laboratory

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: sham iTBS; Device: active iTBS; Behavioral: traditional 1on1 course

Study type: Interventional

Funder types: Other

Identifiers

NCT05890846

CPASD2023DL

Details and patient eligibility

About

This study will evaluate the efficacy and safety of pBFS-guided TMS treatment for the core symptom in autism spectrum disorder children, adolescents and young adults.

Full description

Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors. Broad cognitive control function deficit in ASD suggested cognitive control function as a potential phenotype and treatment target. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying cognitive control function based on the task free functional MRI data. The tailored TMS intervention target to cognitive control function network which located in the left dorsal lateral prefrontal cortex (DLPFC) will be selected for each participant by a blinded researcher.

The participants will be equally randomized to the active iTBS to the cognitive control function network, and sham iTBS at a ratio of 2:1. Each participant will receive 5 days of treatment per week for 12 weeks. Functional MRI data under sedation will be collected pre-and post-treatment. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.

Enrollment: 66 estimated patients

Sex: All

Ages: 6 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nearest age 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 parent or other legal guardian 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 one year
• Severe visual, auditory, or motor disability that interferes with any study procedure
• Current or history of seizure
• 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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66 participants in 2 patient groups

DLPFC group

Experimental group

Description:

Active iTBS will be delivered to the cognitive control network at left DLPFC.

Treatment:

Behavioral: traditional 1on1 course

Device: active iTBS

Sham group

Sham Comparator group

Description:

Sham iTBS will be delivered to the cognitive control network at left DLPFC.

Treatment:

Behavioral: traditional 1on1 course

Device: sham iTBS