Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07579494

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Right Inferior Frontal Gyrus Theta Burst Stimulation

Age range

8 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location status: Recruiting

Location contact

Hsing Chang Ni, PhD

CONTACT

[email protected]

886-3-3281200 ext. 2479

Hsing Chang Ni, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
  • Pregnancy
  • Presence of significant brain abnormalities, such as intracranial space-occupying lesions
  • Previous brain surgery or central nerve system infection
  • Concurrent use of medications which increased the risk of seizure attack
  • Participate in another clinical trial within one month
  • With damaged skin at the stimulated region
  • With multiple sclerosis
  • With large ischemic scars
  • Have experienced sleep disorders during brain stimulation
  • Severe alcoholism
  • Concurrent use of antiepileptic drugs
  • Uncontrollable migraines due to increased intracranial pressure
  • Unsuitable for MRI (e.g. those with claustrophobia)
  • Unsuitable for EEG
  • DSM-5 severity level of ASD: level 3
  • Current major depressive disorder
  • Suicidal ideation within one year
  • Currently taking tricyclic antidepressants (TCAs), analgesics, or any medications known to lower the seizure threshold.

Withdrawal Criteria:

  • Seizure attack during the study period
  • Autistic symptoms worsened obviously during the study period (change of DSM-5 severity level)
  • Extreme agitation or irritability during the study period
  • Participants request
  • Clinical symptoms worsened obviously during study period
  • Start to use antiepileptic drugs during study period
  • Suicidal ideation or self-harm behaviors during study period
  • Changes in the frequency or dosage of concurrent treatments during the study period.

Treatment and study plan

Intermittent Theta Burst Stimulation

Device

stimulatory protocol

Primary outcomes

  1. Changes of total scores of Social Responsiveness Scale

    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)

    Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.

  2. Changes of total scores of Repetitive Behavior Scale-Revised

    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)

    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

  1. Changes of total scores of Emotional Dysregulation Inventory

    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)

    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.

  2. Changes of total scores of Child Behavior Checklist

    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)

    CBCL is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.

  3. Changes of total scores of Anxiety Scale for Autism

    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)

    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.

  4. Changes of total scores of Adaptive Behavior Assessment System

    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)

    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.

  5. Accuracy of Frith-Happe Animation

    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)

    A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better social cognition.

  6. Accuracy of Eyes Task

    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)

    An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.

  7. Accuracy of Wisconsin Card Sorting Test

    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)

    An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility.

  8. Changes of total scores of Behavior Rating Inventory of Executive Function

    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)

    Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The score ranges from 20-110. The lower scores stand for better executive function.

  9. Raven's Progressive Matrices

    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)

    An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.

Other outcomes

  1. MRI T1

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

    Brain structural volumes (cm²).

  2. Functional MRI (Resting-state/Biological Motion Task) - BOLD Signal

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

    Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.

  3. DTI Mean-FA Tractometry - Left Arcuate Fasciculus (AF_left)

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

    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.

  4. Electroencephalography

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hsing-Chang Ni, Ph.D

CONTACT

[email protected]

88633281200 ext. 2479

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.