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NCT Number: NCT06974838

Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability

The investigator would like to investigate the impact of theta-burst stimulation over left DLPFC in autism with minimally verbal ability or intellectual disability

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Intellectual Disability Mental Disorders Minimally Verbal Ability Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

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

  • Diagnosis of autism spectrum disorder, confirmed by DSM-5.
  • Individuals with minimal verbal ability or intellectual disability (FSIQ < 70).

Exclusion criteria

  • Current or past severe neurological disorders, such as epilepsy, or significant visual or hearing impairments.
  • Current or past severe systemic diseases, such as cardiovascular disease, diabetes, or multiple sclerosis.
  • History of severe brain injury.
  • Presence of implanted metal devices, such as a pacemaker or medication pump.
  • Current or past severe psychiatric disorders, such as schizophrenia, bipolar disorder, or major depressive disorder.
  • Pregnancy.
  • Significant brain abnormalities, such as intracranial space-occupying lesions.
  • Family history of epilepsy.
  • History of febrile seizures.
  • Concurrent use of medications that increase the risk of seizures.
  • Sleep disorders during rTMS procedures.
  • Skin lesions or trauma at the stimulation site.
  • Deemed ineligible by the principal investigator (PI).
  • Participation in another clinical trial within the past month.
  • Suicidal ideation or suicide attempts within the past year.

Treatment and study plan

Intermittent Theta Burst Stimulation

Device

stimulatory protocol

Primary outcomes

  1. Total Scores of Aberrant Behavior Checklist

    Time frame: Baseline, Week 4, Week 8 and Week 12

    Aberrant Behavior Checklist is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.

  2. Total Scores of Emotional Dysregulation Inventory

    Time frame: Baseline, Week 4, Week 8 and Week 12

    Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The lower scores stand for better emotional regulation.

  3. Total Scores of Child Behavior Checklist

    Time frame: Baseline, Week 4, Week 8 and Week 12

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

Secondary outcomes

  1. Total Scores of Social Responsiveness Scale

    Time frame: Baseline, Week 4, Week 8 and Week 12

    Social Responsiveness Scale can measure the autism clinical severity. The lower scores stand for better social responsiveness.

  2. Total Scores of Repetitive Behavior Scale-Revised

    Time frame: Baseline, Week 4, Week 8 and Week 12

    Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The lower scores stand for lower repetitive behavior.

  3. Total Scores of Adaptive Behavior Assessment System

    Time frame: Baseline, Week 4, Week 8 and Week 12

    Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The higher scores stand for better adaptive behavior.

  4. Total Scores of Anxiety, Depression, and Mood Scale

    Time frame: Baseline, Week 4, Week 8 and Week 12

    Anxiety, Depression, and Mood Scale is a parents' report questionnaire for mental disorders (manic/ hyperactive behavior, depressed mood, social avoidance, general anxiety, obsessive/compulsive behavior) . The higher scores stand for higher mental problem.

  5. Accuracy of Frith-Happe Animation

    Time frame: Baseline, Week 4, Week 8 and Week 12

    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, Week 4, Week 8 and Week 12

    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, Week 4, Week 8 and Week 12

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

  8. Accuracy of Raven's Progressive Matrices

    Time frame: Baseline, Week 4, Week 8 and Week 12

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

  9. Total Scores of Behavior Rating Inventory of Executive Function

    Time frame: Baseline, Week 4, Week 8 and Week 12

    Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The lower scores stand for better executive function.

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
2025
Primary completion
2029
Study completion
2029
First posted
May 16, 2025
Registry last updated
May 16, 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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