Not yet recruiting NCT06974838
Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intermittent theta burst stimulation.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder, Minimally Verbal Ability, Intellectual Disability. Basic parameters: 8 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The investigator would like to investigate the impact of theta-burst stimulation over left DLPFC in autism with minimally verbal ability or intellectual disability
Interventions
- Device intermittent theta burst stimulation
stimulatory protocol
Primary outcome measures
- Total Scores of Aberrant Behavior Checklist [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Total Scores of Emotional Dysregulation Inventory [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Total Scores of Child Behavior Checklist [Time frame: Baseline, Week 4, Week 8 and Week 12]
Secondary outcome measures (9)
- Total Scores of Social Responsiveness Scale [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Total Scores of Repetitive Behavior Scale-Revised [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Total Scores of Adaptive Behavior Assessment System [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Total Scores of Anxiety, Depression, and Mood Scale [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Accuracy of Frith-Happe Animation [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Accuracy of Eyes Task [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Accuracy of Wisconsin Card Sorting Test [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Accuracy of Raven's Progressive Matrices [Time frame: Baseline, Week 4, Week 8 and Week 12]
- Total Scores of Behavior Rating Inventory of Executive Function [Time frame: Baseline, Week 4, Week 8 and Week 12]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Chang Gung Memorial Hospital — Taoyuan
Identifiers
NCT: NCT06974838 · 202302085A0