The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder

NCT04987541 | Unknown

• 1 other identifier: 202002498A0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator would like to investigate the impact of intermittent theta burst stimulation over left dorsolateral prefrontal cortex on emotion regulation in autism spectrum disorder

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• Changes of total scores of Emotional Dysregulation Inventory

  Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.

  baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)

• Changes of total scores of Aberrant Behavior Checklist

  ABC is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.

  baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)

• Changes of total scores of Child Behavior Checklist

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

  baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)

Secondary Outcomes (12)

• Changes of total scores of Social Responsiveness Scale

  baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)

• Changes of total scores of Repetitive Behavior Scale-Revised

  baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)

• Changes of total scores of Adaptive Behavior Assessment System

  baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)

• Changes in accuracy of Frith-Happe animation

  baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)

• Changes in accuracy of Eyes task

  baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)

Study Arms (2)

Active

EXPERIMENTAL

Participants received the real intervention of TBS (iTBS 600) 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 (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:

• autism spectrum disorder, confirmed by ADOS

You may not qualify if:

• Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment
• Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection
• Previous or current severe brain injury
• Implementation of metal materials such as pacemaker or medication pump
• Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
• Pregnancy
• Individuals with a significant brain abnormality such as intracranial space occupied lesions
• Individuals with a family history of epilepsy
• Previous febrile seizures
• Current taking antiepileptic drugs
• Concurrent use of medications which increased the risk of seizure attack
• Individuals suffering from sleep deprivation during rTMS procedures
• Skin trauma on application site
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
• Participate another clinical trial within one month

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Hsing-Chang Ni, Dr.

CONTACT

88633281200; alanni0918@yahoo.com.tw

Study Design

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

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 3, 2021
• Study Start: September 6, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

TW (1)