Autism Spectrum DisorderNCT06974838
Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability
A study testing intermittent theta burst stimulation in people with Autism Spectrum Disorder and Minimally Verbal Ability, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 8 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder, Minimally Verbal Ability, Intellectual Disability
- What is being tested?
- intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of autism spectrum disorder, confirmed by DSM-5.
- Individuals with minimal verbal ability or intellectual disability (FSIQ < 70).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan
Hsing Chang Ni, Ph.D, 886-3-3281200 ext. 2479, alanni0918@yahoo.com.tw
Hsing Chang Ni, Ph.D
About this study
The investigator would like to investigate the impact of theta-burst stimulation over left DLPFC in autism with minimally verbal ability or intellectual disability
- Being tested
- intermittent theta burst stimulation
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulationDevice
stimulatory protocol
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | 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 Receives: Device: intermittent theta burst stimulation |
| Sham group | Sham comparator | Participants received the sham intervention of TBS (with sham coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). Receives: Device: intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8 and Week 12
Secondary outcomes (9)
Total Scores of Social Responsiveness Scale
Social Responsiveness Scale can measure the autism clinical severity. The lower scores stand for better social responsiveness.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start8 Aug 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974838
- Sponsor's protocol ID
- 202302085A0
- Status last verified
- Sep 2026
- First submitted
- 14 May 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability
- ClinicalTrials.gov ID
- NCT06974838
- Acronym / sponsor ID
- 202302085A0
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Device: intermittent theta burst stimulationParticipants 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 |
| Sham group | Sham comparator | Device: intermittent theta burst stimulationParticipants received the sham intervention of TBS (with sham coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of autism spectrum disorder, confirmed by DSM-5.
- Individuals with minimal verbal ability or intellectual disability (FSIQ < 70).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent theta burst stimulationstimulatory protocol | Device | Active group, Sham group |
Primary outcome
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.
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.
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.
9 secondary outcomes
Total Scores of Social Responsiveness Scale
Time frame: Baseline, Week 4, Week 8 and Week 12
Total Scores of Repetitive Behavior Scale-Revised
Time frame: Baseline, Week 4, Week 8 and Week 12
Total Scores of Adaptive Behavior Assessment System
Time frame: Baseline, Week 4, Week 8 and Week 12
Total Scores of Anxiety, Depression, and Mood Scale
Time frame: Baseline, Week 4, Week 8 and Week 12
Accuracy of Frith-Happe Animation
Time frame: Baseline, Week 4, Week 8 and Week 12
Accuracy of Eyes Task
Time frame: Baseline, Week 4, Week 8 and Week 12
Accuracy of Wisconsin Card Sorting Test
Time frame: Baseline, Week 4, Week 8 and Week 12
Accuracy of Raven's Progressive Matrices
Time frame: Baseline, Week 4, Week 8 and Week 12
Total Scores of Behavior Rating Inventory of Executive Function
Time frame: Baseline, Week 4, Week 8 and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent theta burst stimulation in people with Autism Spectrum Disorder and Minimally Verbal Ability, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsing-Chang Ni, Ph.D (88633281200 ext. 2479, alanni0918@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Scores of Aberrant Behavior Checklist (time frame: Baseline, Week 4, Week 8 and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.