Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability
NCT ID: NCT06974838
Last Updated: 2025-05-16
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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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-26
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
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
intermittent theta burst stimulation
stimulatory protocol
Sham
Participants received the sham intervention of TBS (with sham coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week).
intermittent theta burst stimulation
stimulatory protocol
Interventions
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intermittent theta burst stimulation
stimulatory protocol
Eligibility Criteria
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Inclusion Criteria
* Individuals with minimal verbal ability or intellectual disability (FSIQ \< 70).
Exclusion Criteria
* 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.
* 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.
8 Years
30 Years
ALL
No
Sponsors
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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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Other Identifiers
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202302085A0
Identifier Type: -
Identifier Source: org_study_id
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