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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-30
SponsorChang Gung Memorial Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of autism spectrum disorder, confirmed by DSM-5.

Individuals with minimal verbal ability or intellectual disability (FSIQ < 70).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • intermittent theta burst stimulation

    Device

    stimulatory protocol

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Active groupActive comparator 1 intervention
Group B: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Scores of Aberrant Behavior Checklist

Aberrant Behavior Checklist is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.

Time frame
Baseline, Week 4, Week 8 and Week 12
2

Total Scores of Emotional Dysregulation Inventory

Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The lower scores stand for better emotional regulation.

Time frame
Baseline, Week 4, Week 8 and Week 12
3

Total Scores of Child Behavior Checklist

Child Behavior Checklist is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.

Time frame
Baseline, Week 4, Week 8 and Week 12

Secondary outcomes

1

Total Scores of Social Responsiveness Scale

Social Responsiveness Scale can measure the autism clinical severity. The lower scores stand for better social responsiveness.

Time frame
Baseline, Week 4, Week 8 and Week 12
2

Total Scores of Repetitive Behavior Scale-Revised

Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The lower scores stand for lower repetitive behavior.

Time frame
Baseline, Week 4, Week 8 and Week 12
3

Total Scores of Adaptive Behavior Assessment System

Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The higher scores stand for better adaptive behavior.

Time frame
Baseline, Week 4, Week 8 and Week 12
4

Total Scores of Anxiety, Depression, and Mood Scale

Anxiety, Depression, and Mood Scale is a parents' report questionnaire for mental disorders (manic/ hyperactive behavior, depressed mood, social avoidance, general anxiety, obsessive/compulsive behavior) . The higher scores stand for higher mental problem.

Time frame
Baseline, Week 4, Week 8 and Week 12

Other outcomes

Sponsors and contacts

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