ClinicalTrials.gg
RecruitingNCT06974838Updated Sep 16, 2026

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

An interventional study of intermittent theta burst stimulation in Autism Spectrum Disorder, Minimally Verbal Ability and Intellectual Disability, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 8 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
8 Years to 30 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Autism Spectrum Disorder
  • Minimally Verbal Ability
  • Intellectual Disability
03

In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's planned enrollment of 60 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Active group

    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

  • Sham comparator
    Sham group

    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

Interventions

  • Deviceintermittent theta burst stimulation

    stimulatory protocol

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes

  1. Total Scores of Social Responsiveness Scale

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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. Accuracy of Eyes Task

    An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06974838
Responsible party
Sponsor
First posted
May 16, 2025
Start date
Aug 8, 2025
Primary completion
Jul 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Hsing-Chang Ni, Ph.D
Contact
alanni0918@yahoo.com.tw
88633281200 ext. 2479

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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