Autism Spectrum DisorderNCT07114770
Explore the Impacts of One Session and Multiple Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
A study testing Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation) in people with Autism Spectrum Disorder and Theta Burst Stimulation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to establish a personalized theta burst stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation, rTMS) protocol considering autistic idiosyncrasy (interindividual variability). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Theta Burst Stimulation
- What is being tested?
- Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jul 2025to 31 Dec 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Autistic adults (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.
- DSM-5 severity level of ASD: level 1 or level 2
- ≥18 years old without autism spectrum disorder
Who cannot join
- Previous or current severe neurological disorders, especially epilepsy
- 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, severe major depressive disorder or substance abuse
- Pregnancy
Show all 29Show fewer
- Intracranial space occupied 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
- Suicidal ideation within one year
- 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
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
This study aims to establish a personalized theta burst stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation, rTMS) protocol considering autistic idiosyncrasy (interindividual variability).
- Conditions
- Autism Spectrum Disorder, Theta Burst Stimulation
- Being tested
- Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic 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.
Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)Device
Participants will receive a single session of either iTBS or cTBS (600 pulses) targeting the right cerebellar Crus I/II. One week after the initial TBS, they will receive another single session of iTBS or cTBS (600 pulses) at the same site.
| Study group | Role | What they receive |
|---|---|---|
| Autistic adults | Experimental | Eligible participants are adults diagnosed with autism who meet the inclusion criteria of the study. Receives: Device: Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation) |
| Typically developing adults | Active comparator | Eligible participants are typically developing adults who meet the study's inclusion criteria. Receives: Device: Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional MRI (default mode network) - BOLD Signal
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
Measured: Baseline, Week 1, Week 2
MEP amplitude
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
Measured: Baseline
MEP amplitude
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
Measured: Week 1 (5 minutes post-TBS)
MEP amplitude
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
Measured: Week 2 (5 minutes post-TBS)
MEP amplitude
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
Measured: Week 1 (10 minutes post-TBS)
MEP amplitude
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
Measured: Week 2 (10 minutes post-TBS)
MEP amplitude
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
Measured: Week 1 (15 minutes post-TBS)
MEP amplitude
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
Measured: Week 2 (15 minutes post-TBS)
MEP amplitude
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
Measured: Week 1 (20 minutes post-TBS)
MEP amplitude
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
Measured: Week 2 (20 minutes post-TBS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start29 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114770
- Sponsor's protocol ID
- 202500396A0
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Impacts of One Session and Multiple Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07114770
- Acronym / sponsor ID
- 202500396A0
- Conditions
- Autism Spectrum Disorder, Theta Burst Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Aug 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.
This study aims to establish a personalized theta burst stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation, rTMS) protocol considering autistic idiosyncrasy (interindividual variability).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autistic adults | Experimental | Device: Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)Eligible participants are adults diagnosed with autism who meet the inclusion criteria of the study. |
| Typically developing adults | Active comparator | Device: Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)Eligible participants are typically developing adults who meet the study's inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Autistic adults (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.
- DSM-5 severity level of ASD: level 1 or level 2
- ≥18 years old without autism spectrum disorder
Key exclusion criteria (29 listed)
- Previous or current severe neurological disorders, especially epilepsy
- 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, severe major depressive 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 |
|---|---|---|
| Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)Participants will receive a single session of either iTBS or cTBS (600 pulses) targeting the right cerebellar Crus I/II. One week after the initial TBS, they will receive another single session of iTBS or cTBS (600 pulses) at the same site. | Device | Autistic adults, Typically developing adults |
Primary outcome
Functional MRI (default mode network) - BOLD Signal
Time frame: Baseline, Week 1, Week 2
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
MEP amplitude
Time frame: Baseline
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
MEP amplitude
Time frame: Week 1 (5 minutes post-TBS)
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
MEP amplitude
Time frame: Week 2 (5 minutes post-TBS)
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
MEP amplitude
Time frame: Week 1 (10 minutes post-TBS)
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
MEP amplitude
Time frame: Week 2 (10 minutes post-TBS)
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
MEP amplitude
Time frame: Week 1 (15 minutes post-TBS)
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
MEP amplitude
Time frame: Week 2 (15 minutes post-TBS)
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
MEP amplitude
Time frame: Week 1 (20 minutes post-TBS)
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
MEP amplitude
Time frame: Week 2 (20 minutes post-TBS)
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
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 11 Aug 2025.
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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 Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic 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 3 inclusion and 29 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 11 Aug 2025. 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. 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?
Functional MRI (default mode network) - BOLD Signal (time frame: Baseline, Week 1, Week 2). The study lists 10 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 11 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.