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

Study Overview

• Status: Not yet recruiting
• Conditions: Intellectual Disability; Autism Spectrum Disorder; Minimally Verbal Ability
• Intervention / Treatment: Device: intermittent theta burst stimulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsing-Chang Ni, Ph.D; Phone Number: 2479 88633281200; Email: alanni0918@yahoo.com.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Participants received the real intervention of TBS (iTBS 1200) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). *iTBS = intermittent theta burst stimulation	Device: intermittent theta burst stimulation; stimulatory protocol
Sham Comparator: Sham; Participants received the sham intervention of TBS (with sham coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week).	Device: intermittent theta burst stimulation; stimulatory protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Scores of Aberrant Behavior Checklist	Aberrant Behavior Checklist is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.	Baseline, Week 4, Week 8 and Week 12
Total Scores of Emotional Dysregulation Inventory	Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The lower scores stand for better emotional regulation.	Baseline, Week 4, Week 8 and Week 12
Total Scores of Child Behavior Checklist	Child Behavior Checklist is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.	Baseline, Week 4, Week 8 and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Scores of Social Responsiveness Scale	Social Responsiveness Scale can measure the autism clinical severity. The lower scores stand for better social responsiveness.	Baseline, Week 4, Week 8 and Week 12
Total Scores of Repetitive Behavior Scale-Revised	Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The lower scores stand for lower repetitive behavior.	Baseline, Week 4, Week 8 and Week 12
Total Scores of Adaptive Behavior Assessment System	Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The higher scores stand for better adaptive behavior.	Baseline, Week 4, Week 8 and Week 12
Total Scores of Anxiety, Depression, and Mood Scale	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.	Baseline, Week 4, Week 8 and Week 12
Accuracy of Frith-Happe Animation	A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition.	Baseline, Week 4, Week 8 and Week 12
Accuracy of Eyes Task	An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.	Baseline, Week 4, Week 8 and Week 12
Accuracy of Wisconsin Card Sorting Test	An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility.	Baseline, Week 4, Week 8 and Week 12
Accuracy of Raven's Progressive Matrices	An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.	Baseline, Week 4, Week 8 and Week 12
Total Scores of Behavior Rating Inventory of Executive Function	Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The lower scores stand for better executive function.	Baseline, Week 4, Week 8 and Week 12

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 26, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 14, 2025
• First Submitted That Met QC Criteria: May 14, 2025
• First Posted (Actual): May 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Intellectual Disability
• Other Study ID Numbers: 202302085A0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No