About this trial
Exploring the therapeutic efficacy of Theta Burst Stimulation (TBS) over the right inferior frontal gyrus (RIFG) in autism, including changes in core symptoms, adaptive functioning, neuropsychological performance, and neurophysiological signals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants aged 8 to 30 years with a clinical diagnosis of Autism Spectrum Disorder (ASD), confirmed by the ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition).
DSM-5 severity level of ASD: level 1 or level 2
Participants who have been on a stable treatment regimen prior to the study, or those for whom conventional treatments have been assessed as ineffective by a physician, or those who decline conventional treatment.
A score of ≥ 15 on the University of California Brief Assessment of Capacity to Consent (UBACC) and demonstrated understanding of study aims and risks via the teach-back method.
Disqualifiers
Previous or current severe neurological disorders, especially epilepsy, visual or auditory impairments
Previous or current severe systemic diseases such as cardiovascular disease, diabetes or hypertension
Previous or current severe brain injury
Implementation of metal materials such as a pacemaker or medication pump
Trial design
Parallel
Treatments tested in this trial
intermittent theta burst stimulation
Devicestimulatory protocol
Treatment groups
Trial outcomes
Primary outcomes
Changes of total scores of Social Responsiveness Scale
Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
Changes of total scores of Repetitive Behavior Scale-Revised
Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior.
Secondary outcomes
Changes of total scores of Emotional Dysregulation Inventory
Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.
Changes of total scores of Child Behavior Checklist
CBCL is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.
Changes of total scores of Anxiety Scale for Autism
ASA is a parents' report questionnaire for severity of anxiety in children with ASD. The score ranges from 0-72. The lower scores stand for better emotional regulation.
Changes of total scores of Adaptive Behavior Assessment System
Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 40-120. The higher scores stand for better adaptive behavior.
Other outcomes
MRI T1
Brain structural volumes (cm²).
Functional MRI (Resting-state/Biological Motion Task) - BOLD Signal
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
DTI Mean-FA Tractometry - Left Arcuate Fasciculus (AF_left)
This outcome is the mean fractional anisotropy (FA) of the left arcuate fasciculus (AF\_left) computed using DTI-based tractometry. FA is a unitless metric (range 0-1) that reflects the degree of diffusion anisotropy. A diffusion tensor was fitted to the diffusion MRI data to generate FA maps, and FA values were sampled within the AF\_left tract mask/tract reconstruction and averaged to yield one mean FA value per participant per time point.
Electroencephalography
Resting state EEG (alpha power / frontal gamma power).
Sponsors and contacts
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