One-session versus multiple-session theta burst stimulation over the cerebellum in adults with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with autism (confirmed by ADOS and DSM-5 severity level 1 or 2) and a group of typically developing adults will receive theta burst stimulation (TBS) targeted to the cerebellum. The protocol adapts stimulation parameters to individual neurophysiology to account for autistic idiosyncrasy and compares a single-session regimen to a multiple-session regimen. Participants are screened to exclude conditions that increase seizure risk or contraindicate TBS (for example, epilepsy, metal implants, or severe psychiatric/medical comorbidity). Outcomes will include clinical symptom measures and neurophysiological markers collected before and after stimulation to detect changes over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Chang Gung Memorial Hospital
  Taoyuan, Taiwan Recruiting

Study contacts

• Study coordinator: Hsing-Chang Ni, Ph.D
• Email: alanni0918@yahoo.com.tw
• Phone: 88633281200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.