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

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Device: active iTBS; Device: sham iTBS; Behavioral: traditional 1on1 course

• Registration Number: NCT05890846
• Lead Sponsor: Changping Laboratory

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-06-25
• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2024-09-20
• Study Completion: 2025-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DLPFC group	active iTBS	Active iTBS will be delivered to the cognitive control network at left DLPFC.
Sham group	sham iTBS	Sham iTBS will be delivered to the cognitive control network at left DLPFC.
DLPFC group	traditional 1on1 course	Active iTBS will be delivered to the cognitive control network at left DLPFC.
Sham group	traditional 1on1 course	Sham iTBS will be delivered to the cognitive control network at left DLPFC.

Primary Outcome Measures

Name	Time	Method
Response rate after 12 weeks treatment	Pre-treatment (baseline), after 12-weeks treatment	Treatment response is defined as improvement, i.e., scores decreased, in both the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom.

Secondary Outcome Measures

Name	Time	Method
SCQ score change	Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment	SCQ score change from baseline. Higher scores mean a worse outcome.
Response rate after 8 weeks treatment	Pre-treatment (baseline), after 8-weeks treatment	Treatment response is defined as improvement, i.e., scores decreased, in the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom.
SRS-2 score change	Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment	Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.
ADOS-2 total score change	Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment	The ADOS-2 total score change from baseline. Higher scores mean a worse outcome.
ADOS-2 SA score change	Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment	The ADOS-2 SA score changes from baseline. Higher scores mean a worse outcome.
CBCL score change	Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment	Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.

Trial Locations

Locations (2)

China Rehabilitation Research Center; 🇨🇳 Beijing, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China