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NCT Number: NCT07114770

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

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).

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Theta Burst Stimulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location status: Recruiting

Location contact

Hsing Chang Ni, Ph.D

CONTACT

[email protected]

886-3-3281200 ext. 2479

Hsing Chang Ni, Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Functional MRI (default mode network) - BOLD Signal

    Time frame: Baseline, Week 1, Week 2

    Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.

  2. MEP amplitude

    Time frame: Baseline

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

  3. MEP amplitude

    Time frame: Week 1 (5 minutes post-TBS)

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

  4. MEP amplitude

    Time frame: Week 2 (5 minutes post-TBS)

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

  5. MEP amplitude

    Time frame: Week 1 (10 minutes post-TBS)

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

  6. MEP amplitude

    Time frame: Week 2 (10 minutes post-TBS)

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

  7. MEP amplitude

    Time frame: Week 1 (15 minutes post-TBS)

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

  8. MEP amplitude

    Time frame: Week 2 (15 minutes post-TBS)

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

  9. MEP amplitude

    Time frame: Week 1 (20 minutes post-TBS)

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

  10. MEP amplitude

    Time frame: Week 2 (20 minutes post-TBS)

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

Study contacts

Contact information is provided by the study sponsor or research team.

Hsing-Chang Ni, Ph.D

CONTACT

[email protected]

88633281200 ext. 2479

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • National Health Research Institutes, Taiwan

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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