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Search / Trial NCT06974838

Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability

Launched by CHANG GUNG MEMORIAL HOSPITAL · May 14, 2025

Trial Information

Current as of July 24, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how a special type of brain stimulation, called theta-burst stimulation, can help people with autism who have minimal verbal abilities or intellectual disabilities manage their emotions better. Researchers want to understand if this treatment can improve emotional regulation in individuals diagnosed with autism spectrum disorder (ASD). The trial is not yet recruiting participants, but it aims to include individuals aged between 8 and 30 years old, regardless of gender.

To be eligible for this study, participants must have a confirmed diagnosis of autism spectrum disorder and have minimal verbal ability or an intellectual disability, which means their IQ is below 70. However, certain individuals will not be able to participate. This includes those with serious neurological or systemic diseases, a history of severe brain injuries, implanted metal devices, or severe psychiatric disorders. If eligible, participants can expect to receive theta-burst stimulation treatment and will be carefully monitored throughout the trial to ensure their safety. This study could provide valuable insights into new ways to support emotional well-being in individuals with autism.

Gender

ALL

Eligibility criteria

  • 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.

About Chang Gung Memorial Hospital

Chang Gung Memorial Hospital, one of the largest healthcare organizations in Taiwan, is renowned for its commitment to advancing medical research and improving patient care. As a clinical trial sponsor, the hospital leverages its extensive clinical expertise and state-of-the-art facilities to conduct innovative research across various medical disciplines. With a focus on collaboration and ethical practices, Chang Gung Memorial Hospital aims to contribute to the global body of medical knowledge through rigorous clinical trials that enhance treatment options and improve health outcomes for patients.

Locations

Taoyuan, , Taiwan

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported