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

Overview

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.

Interventions

• Device intermittent theta burst stimulation
  stimulatory protocol

Primary outcome measures

• 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)]
• 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)]

Secondary outcome measures (9)

• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Chang Gung Memorial Hospital — Taoyuan

Identifiers

NCT: NCT07579494 · 202401962A0

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗