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

Autism Spectrum Disorder Clinical Trial

Official title:

Personalized Brain Functional Sectors (pBFS) Guided Noninvasive Neuromodulation Treatment for Pre-school Children With Autism Spectrum Disorder (ASD): a Single-center, Double-blinded, Sham-Controlled, Randomized Clinical Trial Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06031948
• Other study ID #: CPLASD2023HNC50
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 1, 2025

Study information

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

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Months to 6 Years

Eligibility

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

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.
• 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.
• 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
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Changping Laboratory	Henan Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SCQ score change	Score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), immediately post-treatment
Other	SRS-2 score change	Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), immediately post-treatment
Other	RBS-R score change	Score change of the Repetitive Behavior Scale-Revised (RBS-R) from baseline. Higher scores mean a worse outcome.	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. Higher scores mean a worse outcome.	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. Higher scores mean a worse outcome.	Pre-treatment (baseline), immediately post-treatment
Secondary	CBCL score change	Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), immediately post-treatment