Explore the Impacts of One Session and Multiple Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
NCT ID: NCT07114770
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-29
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Autistic adults
Eligible participants are adults diagnosed with autism who meet the inclusion criteria of the study.
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.
Typically developing adults
Eligible participants are typically developing adults who meet the study's inclusion criteria.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* DSM-5 severity level of ASD: level 1 or level 2
* ≥18 years old without autism spectrum disorder
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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National Health Research Institutes, Taiwan
OTHER
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202500396A0
Identifier Type: -
Identifier Source: org_study_id
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