RecruitingNot ApplicableNCT07114770

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


Sponsor

Chang Gung Memorial Hospital

Enrollment

60 participants

Start Date

Jul 29, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Autistic adults (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.
  • DSM-5 severity level of ASD: level 1 or level 2
  • ≥18 years old without autism spectrum disorder

Exclusion Criteria29

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETheta 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.


Locations(1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07114770


Related Trials