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Clinical Trials in Taiwan / NCT07114770
Recruiting Not applicable

Explore the Impacts of One Session and Multiple Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

NCT07114770 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Chang Gung Memorial Hospital
Phase
Not applicable
Started
2025-07-29
Last updated
2025-08-11

Condition(s) studied

Autism Spectrum DisorderTheta Burst Stimulation

Investigational drug(s) / intervention(s)

Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)

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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion criteria for autistic adults: * Autistic adults (≥18 years old), confirmed by Autism Diagnostic Observation Schedule. * DSM-5 severity level of ASD: level 1 or level 2 Inclusion criteria for typically developing control: * ≥18 years old without autism spectrum disorder Exclusion criteria for all participants: * 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 * 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

Primary outcome measure(s)

  • Functional MRI (default mode network) - BOLD Signal — Baseline, Week 1, Week 2
    Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
  • MEP amplitude — Baseline
    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
  • MEP amplitude — Week 1 (5 minutes post-TBS)
    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
  • MEP amplitude — Week 2 (5 minutes post-TBS)
    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
  • MEP amplitude — Week 1 (10 minutes post-TBS)
    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
  • MEP amplitude — Week 2 (10 minutes post-TBS)
    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
  • MEP amplitude — Week 1 (15 minutes post-TBS)
    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
  • MEP amplitude — Week 2 (15 minutes post-TBS)
    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
  • MEP amplitude — Week 1 (20 minutes post-TBS)
    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
  • MEP amplitude — Week 2 (20 minutes post-TBS)
    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

Trial sites (1)

FacilityCityRegionStatus
Chang Gung Memorial Hospital Taoyuan Taiwan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07114770 on ClinicalTrials.gov ↗ ← All trials in Taiwan