Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890846
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-05-26
Brief Title:
Precision TMS Treatment Guided by Personalized Brain Functional Sectors pBFS for ASD
Sponsor:
Changping Laboratory
Organization:
Changping Laboratory
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 21 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
The participants will be equally randomized to the active iTBS to the cognitive control function network and sham iTBS at a ratio of 21 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None