Explore the Impacts of Theta Burst Stimulation Over the Right Inferior Frontal Gyrus in Autism Spectrum Disorder: Combination of Clinical Symptoms, Neuropsychological Function and MRI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-30
SponsorChang Gung Memorial Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • intermittent theta burst stimulation

    Device

    stimulatory protocol

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ActiveExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
2

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.

Time frame
baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

Secondary outcomes

1

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.

Time frame
baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
2

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.

Time frame
baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
3

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.

Time frame
baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
4

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.

Time frame
baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

Other outcomes

1

MRI T1

Brain structural volumes (cm²).

Time frame
baseline; post TBS (4 weeks after baseline)
2

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.

Time frame
baseline; post TBS (4 weeks after baseline)
3

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.

Time frame
baseline; post TBS (4 weeks after baseline)
4

Electroencephalography

Resting state EEG (alpha power / frontal gamma power).

Time frame
baseline; post TBS (4 weeks after baseline)

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