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Feasibility and Tolerability of Daily Theta Burst Stimulation in Autistic Youth with Intellectual Disabilities and Minimally Speaking Status: A Pilot Double-Blind Randomized Sham-Controlled Trial.

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Title: Feasibility and Tolerability of Daily Theta Burst Stimulation in Autistic Youth with Intellectual Disabilities and Minimally Speaking Status: A Pilot Double-Blind Randomized Sham-Controlled Trial.
Authors: Ni, Hsing-Chang (AUTHOR), Chen, Yi-Lung (AUTHOR), Lin, Hsiang-Yuan (AUTHOR)
Source: Journal of Autism & Developmental Disorders. Dec2025, Vol. 55 Issue 12, p4262-4271. 10p.
Subjects: Treatment of language disorders, Patient safety, Academic medical centers, Placebos, T-test (Statistics), Research funding, Autism, Prefrontal cortex, Pilot projects, Blind experiment, Statistical sampling, Treatment effectiveness, Randomized controlled trials, Classification of mental disorders, Treatment duration, Chi-squared test, Descriptive statistics, Intellectual disabilities, Asperger's syndrome, Medical screening, Data analysis software, People with disabilities, Transcranial magnetic stimulation, Evaluation
Geographic Terms: Taiwan
Abstract: Scarce clinical trials involving autistic people with intellectual disability (ID) and minimally speaking (MS) status have been a substantial unmet research need in the field. Although earlier studies have demonstrated the feasibility and beneficial potentials of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) in intellectually able autistic people, the feasibility and tolerability of applying rTMS in autistic people with ID/MS has never been studied. We conducted the world-first 4-week randomized, double-blind, sham-controlled pilot trial to investigate the feasibility, tolerability, and safety of intermittent theta burst stimulation (iTBS, a variant of excitatory rTMS) over the left DLPFC in autistic youth with ID/MS. 25 autistic youth with ID/MS (aged 8–30 years) were randomized to a 20-session 4-week daily iTBS (n = 13) vs. sham stimulation (n = 12) with follow-up 4 and 8 weeks, respectively, after the last stimulation. A retention rate was 100% in our study. Adverse events of local pain (38%) and dizziness (8%) were only noted in the active group. All adverse events were mild and transient. There were no seizures, new behavioral problems, or other severe/serious adverse events noted. No participants dropped out due to adverse events. With a small sample size, we did not find any beneficial signal of DLPFC iTBS. Our pilot data suggest regular daily TBS treatment for four weeks is feasible, well tolerated and safe in autistic youth with ID/MS. Future randomized controlled trials with sufficiently powered samples are needed to investigate the beneficial potential of rTMS/TBS for autistic people with ID/MS. [ABSTRACT FROM AUTHOR]
Copyright of Journal of Autism & Developmental Disorders is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Feasibility and Tolerability of Daily Theta Burst Stimulation in Autistic Youth with Intellectual Disabilities and Minimally Speaking Status: A Pilot Double-Blind Randomized Sham-Controlled Trial.
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  Data: <searchLink fieldCode="JN" term="%22Journal+of+Autism+%26+Developmental+Disorders%22">Journal of Autism & Developmental Disorders</searchLink>. Dec2025, Vol. 55 Issue 12, p4262-4271. 10p.
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  Data: Scarce clinical trials involving autistic people with intellectual disability (ID) and minimally speaking (MS) status have been a substantial unmet research need in the field. Although earlier studies have demonstrated the feasibility and beneficial potentials of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) in intellectually able autistic people, the feasibility and tolerability of applying rTMS in autistic people with ID/MS has never been studied. We conducted the world-first 4-week randomized, double-blind, sham-controlled pilot trial to investigate the feasibility, tolerability, and safety of intermittent theta burst stimulation (iTBS, a variant of excitatory rTMS) over the left DLPFC in autistic youth with ID/MS. 25 autistic youth with ID/MS (aged 8–30 years) were randomized to a 20-session 4-week daily iTBS (n = 13) vs. sham stimulation (n = 12) with follow-up 4 and 8 weeks, respectively, after the last stimulation. A retention rate was 100% in our study. Adverse events of local pain (38%) and dizziness (8%) were only noted in the active group. All adverse events were mild and transient. There were no seizures, new behavioral problems, or other severe/serious adverse events noted. No participants dropped out due to adverse events. With a small sample size, we did not find any beneficial signal of DLPFC iTBS. Our pilot data suggest regular daily TBS treatment for four weeks is feasible, well tolerated and safe in autistic youth with ID/MS. Future randomized controlled trials with sufficiently powered samples are needed to investigate the beneficial potential of rTMS/TBS for autistic people with ID/MS. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Journal of Autism & Developmental Disorders is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1007/s10803-024-06477-1
    Languages:
      – Code: eng
        Text: English
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      Pagination:
        PageCount: 10
        StartPage: 4262
    Subjects:
      – SubjectFull: Treatment of language disorders
        Type: general
      – SubjectFull: Patient safety
        Type: general
      – SubjectFull: Academic medical centers
        Type: general
      – SubjectFull: Placebos
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      – SubjectFull: T-test (Statistics)
        Type: general
      – SubjectFull: Research funding
        Type: general
      – SubjectFull: Autism
        Type: general
      – SubjectFull: Prefrontal cortex
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      – SubjectFull: Pilot projects
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      – SubjectFull: Blind experiment
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      – SubjectFull: Statistical sampling
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      – SubjectFull: Treatment effectiveness
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      – SubjectFull: Randomized controlled trials
        Type: general
      – SubjectFull: Classification of mental disorders
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      – SubjectFull: Treatment duration
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      – SubjectFull: Chi-squared test
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      – SubjectFull: Intellectual disabilities
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      – SubjectFull: Asperger's syndrome
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      – SubjectFull: Medical screening
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      – SubjectFull: People with disabilities
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      – SubjectFull: Transcranial magnetic stimulation
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      – SubjectFull: Evaluation
        Type: general
      – SubjectFull: Taiwan
        Type: general
    Titles:
      – TitleFull: Feasibility and Tolerability of Daily Theta Burst Stimulation in Autistic Youth with Intellectual Disabilities and Minimally Speaking Status: A Pilot Double-Blind Randomized Sham-Controlled Trial.
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            NameFull: Ni, Hsing-Chang
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            NameFull: Chen, Yi-Lung
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            – D: 01
              M: 12
              Text: Dec2025
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              Y: 2025
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