Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Chang Gung Memorial Hospital

Conditions:

Autism Spectrum Disorder

Minimally Verbal Ability

Eligibility:

All Genders

8-30 years

Phase:

NA

Brief Summary

The investigator would like to investigate the impact of theta-burst stimulation over left DLPFC in autism with minimally verbal ability or intellectual disability

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

May 26 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2029

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06974838

Start Date

May 26 2025

End Date

December 31 2029

Last Update

May 16 2025

Active Locations (1)

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1

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

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