Clinical trial NCT06974838: Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability
Official title: Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Minimally Verbal Ability
Intellectual Disability
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Total Scores of Aberrant Behavior Checklist
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Total Scores of Emotional Dysregulation Inventory
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Total Scores of Child Behavior Checklist
timeFrame: Baseline, Week 4, Week 8 and Week 12
Secondary outcomes:
measure: Total Scores of Social Responsiveness Scale
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Total Scores of Repetitive Behavior Scale-Revised
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Total Scores of Adaptive Behavior Assessment System
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Total Scores of Anxiety, Depression, and Mood Scale
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Accuracy of Frith-Happe Animation
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Accuracy of Eyes Task
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Accuracy of Wisconsin Card Sorting Test
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Accuracy of Raven's Progressive Matrices
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Total Scores of Behavior Rating Inventory of Executive Function
timeFrame: Baseline, Week 4, Week 8 and Week 12
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: