pBFS Guided Precision Neuromodulation Treatment for ASD

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735262
• Other study ID #: CPASD2023BA100
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2023
• Source: Changping Laboratory
• Contact: Qi Liu
• Phone: 010-80726688
• Email: a0000153[@]cpl.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Device:
• active iTBS
Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
• sham iTBS
Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

Locations

Country	Name	City	State
China	China Rehabilitation Research Center	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Changping Laboratory	China Rehabilitation Research Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SRS-2 score change	Sore change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline	Pre-treatment (baseline), immediately post-treatment
Other	RBS-R score change	Score change of the Repetitive Behavior Scale-Revised (RBS-R) from baseline	Pre-treatment (baseline), immediately post-treatment
Primary	ADOS-2 SA change	The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline	Pre-treatment (baseline), immediately post-treatment
Secondary	ADOS-2 total score change	The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline	Pre-treatment (baseline), immediately post-treatment
Secondary	CBCL score change	Score change of the child behavior checklist (CBCL) from baseline	Pre-treatment (baseline), immediately post-treatment