Theta Burst Stimulation for Emotion Regulation in Autism With Minimal Verbal Ability or Intellectual Disability

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

This interventional study uses intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex in individuals with autism and limited verbal ability or intellectual disability. Eligible participants have an autism diagnosis confirmed by DSM-5 and a full-scale IQ under 70. The study aims to see if this brain stimulation protocol can modulate emotional regulation in this population. Exclusion criteria include serious neurological or systemic diseases, implanted metal devices, pregnancy, significant brain abnormalities, epilepsy risk, and other factors that could affect safety. Location is Chang Gung Memorial Hospital in Taoyuan, Taiwan, led by Chang Gung Memorial Hospital with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of autism spectrum disorder, confirmed by DSM-5.
* Individuals with minimal verbal ability or intellectual disability (FSIQ \< 70).

Exclusion Criteria:

* Current or past severe neurological disorders, such as epilepsy, or significant visual or hearing impairments.
* Current or past severe systemic diseases, such as cardiovascular disease, diabetes, or multiple sclerosis.
* History of severe brain injury.
* Presence of implanted metal devices, such as a pacemaker or medication pump.
* Current or past severe psychiatric disorders, such as schizophrenia, bipolar disorder, or major depressive disorder.
* Pregnancy.
* Significant brain abnormalities, such as intracranial space-occupying lesions.
* Family history of epilepsy.
* History of febrile seizures.
* Concurrent use of medications that increase the risk of seizures.
* Sleep disorders during rTMS procedures.
* Skin lesions or trauma at the stimulation site.
* Deemed ineligible by the principal investigator (PI).
* Participation in another clinical trial within the past month.
* Suicidal ideation or suicide attempts within the past year.

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.