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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Active, not recruiting

Conditions

Autism Spectrum Disorder

Treatments

Device: intermittent theta burst stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05578261
202200409A0

Details and patient eligibility

About

The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults with autism spectrum disorder (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.

Exclusion criteria

  • Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment.
  • Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection.
  • Previous or current severe brain injury
  • Implementation of metal materials such as pacemaker or medication pump
  • Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
  • Pregnancy
  • Individuals with a significant brain abnormality such as intracranial space occupied lesions
  • History of brain surgery or nervous system infection, such as meningitis and encephalitis
  • Concurrent use of medications which increased the risk of seizure attack
  • Participate another clinical trial within one month
  • Skin trauma on application site
  • Individuals suffering from multiple sclerosis
  • Individuals with a large ischemic scar
  • Individuals suffering from sleep deprivation during rTMS procedures
  • Individuals with a heavy consumption of alcohol
  • Current taking antiepileptic drugs
  • Individuals with a migraine headache from increased intracranial pressure
  • Unable to complete MRI scan

Withdrawal criteria:

  • Seizure attack during study period
  • Autistic symptoms worsened obviously during study period
  • Extreme agitation or irritability during study period
  • Participants request
  • Take antiepileptic drug during study period

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Active
Experimental group
Description:
All of the participants will accept one session iTBS over right Crus I/II. The total pulses of every session are 1200 pulses (600 pulses with 15 minutes interval) \*iTBS = intermittent theta burst stimulation.
Treatment:
Device: intermittent theta burst stimulation

Trial contacts and locations

1

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Central trial contact

Hsing-Chang Ni, Dr.

Data sourced from clinicaltrials.gov

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