Autism Spectrum DisorderNCT07579494
Explore the Impacts of Theta Burst Stimulation Over the Right Inferior Frontal Gyrus in Autism Spectrum Disorder: Combination of Clinical Symptoms, Neuropsychological Function and MRI
A study testing intermittent theta burst stimulation in people with Autism Spectrum Disorder and Theta Burst Stimulation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Exploring the therapeutic efficacy of Theta Burst Stimulation (TBS) over the right inferior frontal gyrus (RIFG) in autism, including changes in core symptoms, adaptive functioning, neuropsychological performance, and neurophysiological signals. Read more about this study
- Who is it for?
- Ages 8 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder, Theta Burst Stimulation, Right Inferior Frontal Gyrus
- 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
- 5 May 2026to 31 Dec 2030
- 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
- Participants aged 8 to 30 years with a clinical diagnosis of Autism Spectrum Disorder (ASD), confirmed by the ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition).
- DSM-5 severity level of ASD: level 1 or level 2
- Participants who have been on a stable treatment regimen prior to the study, or those for whom conventional treatments have been assessed as ineffective by a physician, or those who decline conventional treatment.
- A score of ≥ 15 on the University of California Brief Assessment of Capacity to Consent (UBACC) and demonstrated understanding of study aims and risks via the teach-back method.
Who cannot join
- Previous or current severe neurological disorders, especially epilepsy, visual or auditory impairments
- Previous or current severe systemic diseases such as cardiovascular disease, diabetes or hypertension
- Previous or current severe brain injury
- Implementation of metal materials such as a pacemaker or medication pump
- Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
- Pregnancy
Show all 32Show fewer
- Presence of significant brain abnormalities, such as intracranial space-occupying lesions
- Previous brain surgery or central nerve system infection
- Concurrent use of medications which increased the risk of seizure attack
- Participate in another clinical trial within one month
- With damaged skin at the stimulated region
- With multiple sclerosis
- With large ischemic scars
- Have experienced sleep disorders during brain stimulation
- Severe alcoholism
- Concurrent use of antiepileptic drugs
- Uncontrollable migraines due to increased intracranial pressure
- Unsuitable for MRI (e.g. those with claustrophobia)
- Unsuitable for EEG
- DSM-5 severity level of ASD: level 3
- Current major depressive disorder
- Suicidal ideation within one year
- Currently taking tricyclic antidepressants (TCAs), analgesics, or any medications known to lower the seizure threshold.
- Withdrawal Criteria:
- Seizure attack during the study period
- Autistic symptoms worsened obviously during the study period (change of DSM-5 severity level)
- Extreme agitation or irritability during the study period
- Participants request
- Clinical symptoms worsened obviously during study period
- Start to use antiepileptic drugs during study period
- Suicidal ideation or self-harm behaviors during study period
- Changes in the frequency or dosage of concurrent treatments during the study period.
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, PhD, 886-3-3281200 ext. 2479, alanni0918@yahoo.com.tw
Hsing Chang Ni, PhD
About this study
Exploring the therapeutic efficacy of Theta Burst Stimulation (TBS) over the right inferior frontal gyrus (RIFG) in autism, including changes in core symptoms, adaptive functioning, neuropsychological performance, and neurophysiological signals.
- Being tested
- intermittent theta burst stimulation
- Medical subject headings
- Autism Spectrum Disorder
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 | Experimental | Participants received the intervention of iTBS (The total pulse of every session is 600 pulses) over right inferior frontal gyrus for 4 weeks (5 days/week).
*iTBS = intermittent theta burst stimulation Receives: Device: intermittent theta burst stimulation |
| Sham | Sham comparator | Participants received the sham intervention of iTBS (sham-coil) over right inferior frontal gyrus 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.
Changes of total scores of Social Responsiveness Scale
Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
Measured: baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
Changes of total scores of Repetitive Behavior Scale-Revised
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.
Measured: baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
Secondary outcomes (9)
Changes of total scores of Emotional Dysregulation Inventory
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.
Measured: baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
Changes of total scores of Child Behavior Checklist
CBCL is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.
Measured: baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
Changes of total scores of Anxiety Scale for Autism
ASA is a parents' report questionnaire for severity of anxiety in children with ASD. The score ranges from 0-72. The lower scores stand for better emotional regulation.
Measured: baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
Changes of total scores of Adaptive Behavior Assessment System
Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 40-120. The higher scores stand for better adaptive behavior.
Measured: baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
Changes of total scores of Behavior Rating Inventory of Executive Function
Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The score ranges from 20-110. The lower scores stand for better executive function.
Measured: baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start5 May 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Dec 2030 (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
- NCT07579494
- Sponsor's protocol ID
- 202401962A0
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Impacts of Theta Burst Stimulation Over the Right Inferior Frontal Gyrus in Autism Spectrum Disorder: Combination of Clinical Symptoms, Neuropsychological Function and MRI
- ClinicalTrials.gov ID
- NCT07579494
- Acronym / sponsor ID
- 202401962A0
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 May 2026 (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.
Exploring the therapeutic efficacy of Theta Burst Stimulation (TBS) over the right inferior frontal gyrus (RIFG) in autism, including changes in core symptoms, adaptive functioning, neuropsychological performance, and neurophysiological signals.
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 | Experimental | Device: intermittent theta burst stimulationParticipants received the intervention of iTBS (The total pulse of every session is 600 pulses) over right inferior frontal gyrus for 4 weeks (5 days/week). *iTBS = intermittent theta burst stimulation |
| Sham | Sham comparator | Device: intermittent theta burst stimulationParticipants received the sham intervention of iTBS (sham-coil) over right inferior frontal gyrus 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 (4 listed)
- Participants aged 8 to 30 years with a clinical diagnosis of Autism Spectrum Disorder (ASD), confirmed by the ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition).
- DSM-5 severity level of ASD: level 1 or level 2
- Participants who have been on a stable treatment regimen prior to the study, or those for whom conventional treatments have been assessed as ineffective by a physician, or those who decline conventional treatment.
- A score of ≥ 15 on the University of California Brief Assessment of Capacity to Consent (UBACC) and demonstrated understanding of study aims and risks via the teach-back method.
Key exclusion criteria (32 listed)
- Previous or current severe neurological disorders, especially epilepsy, visual or auditory impairments
- Previous or current severe systemic diseases such as cardiovascular disease, diabetes or hypertension
- Previous or current severe brain injury
- Implementation of metal materials such as a pacemaker or medication pump
- Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
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, Sham |
Primary outcome
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.
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.
9 secondary outcomes
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)
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)
Changes of total scores of Anxiety Scale for Autism
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)
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)
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)
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)
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)
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)
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)
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 12 May 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 Theta Burst Stimulation, 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 4 inclusion and 32 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 12 May 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?
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)). The study lists 2 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 12 May 2026.