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

Autism Spectrum Disorder Clinical Trial

Official title:

Personalized Brain Functional Sectors (pBFS) Guided Transcranial Magnetic Stimulation (TMS) Treatment for Autism Spectrum Disorder (ASD): a Sham-controlled, Double-blinded, Randomized Clinical Trial Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890846
• Other study ID #: CPASD2023DL
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2022
• Est. completion date: September 20, 2025

Study information

• Verified date: April 2024
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 20, 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 30 Years

Eligibility

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

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 12 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 12 weeks.

Behavioral:
• traditional 1on1 course
Between every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 weeks.

Locations

Country	Name	City	State
China	China Rehabilitation Research Center	Beijing
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
Changping Laboratory	China Rehabilitation Research Center, Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate 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.	Pre-treatment (baseline), after 12-weeks treatment
Secondary	Response rate 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.	Pre-treatment (baseline), after 8-weeks treatment
Secondary	ADOS-2 SA score change	The ADOS-2 SA score changes from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), after 8-weeks treatment,after 12-weeks tretment
Secondary	SCQ score change	SCQ score change from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), after 8-weeks treatment,after 12-weeks tretment
Secondary	ADOS-2 total score change	The ADOS-2 total score change from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), after 8-weeks treatment,after 12-weeks tretment
Secondary	CBCL score change	Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), after 8-weeks treatment,after 12-weeks tretment
Secondary	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), after 8-weeks treatment,after 12-weeks tretment