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Active, Not Recruiting

NCT Number: NCT05578209

Therapeutic Impacts of Theta Burst Stimulation Over Bilateral Posterior Superior Temporal Sulcus in Autism Spectrum Disorder

The investigator would like to investigate the impact of intermittent theta burst stimulation over bilateral posterior superior temporal sulcus in autism spectrum disorder

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

8 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule II (CSS≧6)
  • No change in psychiatric drugs within one month

Exclusion criteria

  • Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment
  • Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection
  • Previous or current severe brain injury
  • Implementation of metal materials such as pacemaker or medication pump
  • Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
  • Pregnancy
  • Individuals with a significant brain abnormality such as intracranial space occupied lesions
  • History of brain surgery or nervous system infection, such as meningitis and encephalitis
  • Previous febrile seizures
  • Concurrent use of medications which increased the risk of seizure attack.
  • Participate another clinical trial within one month.
  • Unable to complete MRI scan (claustrophobia)
  • Skin trauma on application site
  • Individuals with a large ischemic scar
  • Individuals suffering from multiple sclerosis
  • Individuals suffering from sleep deprivation during rTMS procedures
  • Individuals with a heavy consumption of alcohol
  • Individuals with a migraine headache from increased intracranial pressure

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 Aberrant 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)

    ABC is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.

  2. 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.

  3. 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.

  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 9-171. The higher scores stand for better adaptive behavior.

  5. Changes in 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. Changes in 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. Changes in 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)

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

  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.

  10. MRI T1

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

    Brain structural volumes (cm²)

  11. 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.

  12. Diffusion Tensor Imaging (DTI) - FA

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

    Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons.

  13. Electroencephalography

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

    Resting state EEG (alpha power / frontal gamma power)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Therapeutic Impacts of Theta Burst Stimulation Over Bilateral Posterior Superior Temporal Sulcus in Autism Spectrum Disorder: a Comprehensive Study Integrating Clinical Symptoms, Neuropsychological Function and MRI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2022
Registry last updated
Jun 4, 2025

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.

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