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

NCT06974838 | Not Yet Recruiting

• 1 other identifier: 202302085A0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Autism Spectrum Disorder; Minimally Verbal Ability; Intellectual Disability

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, Week 4, Week 8 and Week 12

• 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.

  Baseline, Week 4, Week 8 and Week 12

• 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.

  Baseline, Week 4, Week 8 and Week 12

Secondary Outcomes (9)

• Total Scores of Social Responsiveness Scale

  Baseline, Week 4, Week 8 and Week 12

• Total Scores of Repetitive Behavior Scale-Revised

  Baseline, Week 4, Week 8 and Week 12

• Total Scores of Adaptive Behavior Assessment System

  Baseline, Week 4, Week 8 and Week 12

• Total Scores of Anxiety, Depression, and Mood Scale

  Baseline, Week 4, Week 8 and Week 12

• Accuracy of Frith-Happe Animation

  Baseline, Week 4, Week 8 and Week 12

Study Arms (2)

Active

ACTIVE COMPARATOR

Participants received the real intervention of TBS (iTBS 1200) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). \*iTBS = intermittent theta burst stimulation

Device: intermittent theta burst stimulation

Sham

SHAM COMPARATOR

Participants received the sham intervention of TBS (with sham coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week).

Device: intermittent theta burst stimulation

Interventions

intermittent theta burst stimulation DEVICE

stimulatory protocol

Active; Sham

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hsing-Chang Ni, Ph.D

CONTACT

88633281200; alanni0918@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 16, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

TW (1)