Autism Spectrum DisorderNCT05578261
Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
A study testing intermittent theta burst stimulation in people with Autism Spectrum Disorder, 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 cerebellum in adults with autism spectrum disorder Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Dec 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with autism spectrum disorder (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.
Who cannot join
- Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment.
- Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection.
- Previous or current severe brain injury
- Implementation of metal materials such as pacemaker or medication pump
- Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
- Pregnancy
Show all 24Show fewer
- Individuals with a significant brain abnormality such as intracranial space occupied lesions
- History of brain surgery or nervous system infection, such as meningitis and encephalitis
- Concurrent use of medications which increased the risk of seizure attack
- Participate another clinical trial within one month
- Skin trauma on application site
- Individuals suffering from multiple sclerosis
- Individuals with a large ischemic scar
- Individuals suffering from sleep deprivation during rTMS procedures
- Individuals with a heavy consumption of alcohol
- Current taking antiepileptic drugs
- Individuals with a migraine headache from increased intracranial pressure
- Unable to complete MRI scan
- Withdrawal criteria:
- Seizure attack during study period
- Autistic symptoms worsened obviously during study period
- Extreme agitation or irritability during study period
- Participants request
- Take antiepileptic drug during study period
Trial locations and contacts
1 site in 1 country.
About this study
The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder
- Conditions
- Autism Spectrum Disorder
- 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 | All of the participants will accept one session iTBS over right Crus I/II. The total pulses of every session are 1200 pulses (600 pulses with 15 minutes interval)
*iTBS = intermittent theta burst stimulation. Receives: Device: intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects report form (Headache)
Recording adverse effects in participants after iTBS.
Measured: 1 week after iTBS (post iTBS)
Adverse effects report form (Dizziness)
Recording adverse effects in participants after iTBS.
Measured: 1 week after iTBS (post iTBS)
Adverse effects report form (Tinnitus)
Recording adverse effects in participants after iTBS.
Measured: 1 week after iTBS (post iTBS)
Adverse effects report form (Seizure)
Recording adverse effects in participants after iTBS.
Measured: 1 week after iTBS (post iTBS)
Adverse effects report form (Other)
Recording adverse effects in participants after iTBS.
Measured: 1 week after iTBS (post iTBS)
Secondary outcomes (2)
MRI T1
Brain structural volumes (cm²)
Measured: Within one month
functional MRI (resting-state/biological motion task) - BOLD signal
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
Measured: Within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start28 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
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
- NCT05578261
- Sponsor's protocol ID
- 202200409A0
- Status last verified
- Aug 2023
- First submitted
- 11 Oct 2022
- Last updated
- 31 Aug 2023
- 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05578261
- Acronym / sponsor ID
- 202200409A0
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Oct 2022 (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 cerebellum in adults with autism spectrum disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: intermittent theta burst stimulationAll of the participants will accept one session iTBS over right Crus I/II. The total pulses of every session are 1200 pulses (600 pulses with 15 minutes interval) *iTBS = intermittent theta burst stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with autism spectrum disorder (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.
Key exclusion criteria (24 listed)
- Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment.
- Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection.
- Previous or current severe brain injury
- Implementation of metal materials such as 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 |
Primary outcome
Adverse effects report form (Headache)
Time frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Dizziness)
Time frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Tinnitus)
Time frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Seizure)
Time frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Other)
Time frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
2 secondary outcomes
MRI T1
Time frame: Within one month
functional MRI (resting-state/biological motion task) - BOLD signal
Time frame: Within one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 1 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effects report form (Headache) (time frame: 1 week after iTBS (post iTBS)). The study lists 5 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 31 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.