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

NCT07579494 | Recruiting

• 1 other identifier: 202401962A0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Theta Burst Stimulation; Right Inferior Frontal Gyrus

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  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 (9)

• Changes of total scores of Emotional Dysregulation Inventory

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

• Changes of total scores of Child Behavior Checklist

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

• Changes of total scores of Anxiety Scale for Autism

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

• Changes of total scores of Adaptive Behavior Assessment System

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

• Accuracy of Frith-Happe Animation

  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 (4)

• MRI T1

  baseline; post TBS (4 weeks after baseline)

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

  baseline; post TBS (4 weeks after baseline)

• DTI Mean-FA Tractometry - Left Arcuate Fasciculus (AF_left)

  baseline; post TBS (4 weeks after baseline)

Study Arms (2)

Active

EXPERIMENTAL

Participants received the intervention of iTBS (The total pulse of every session is 600 pulses) over right inferior frontal gyrus for 4 weeks (5 days/week). \*iTBS = intermittent theta burst stimulation

Device: intermittent theta burst stimulation

Sham

SHAM COMPARATOR

Participants received the sham intervention of iTBS (sham-coil) over right inferior frontal gyrus for 4 weeks (5 days/week).

Device: intermittent theta burst stimulation

Interventions

intermittent theta burst stimulation DEVICE

stimulatory protocol

Active; Sham

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Hsing-Chang Ni, Ph.D

CONTACT

88633281200; alanni0918@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

TW (1)