Therapeutic Impacts of Theta Burst Stimulation Over Bilateral Posterior Superior Temporal Sulcus in Autism Spectrum Disorder

NCT05578209 | Active Not Recruiting

• 1 other identifier: 202102232A0
• 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 bilateral posterior superior temporal sulcus in autism spectrum disorder

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Changes of total scores of Social Responsiveness Scale

  Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.

  baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

• Changes of total scores of Repetitive Behavior Scale-Revised

  Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior.

  baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

Secondary Outcomes (13)

• Changes of total scores of Aberrant Behavior Checklist

  baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

• Changes of total scores of Emotional Dysregulation Inventory

  baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

• Changes of total scores of Child Behavior Checklist

  baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

• Changes of total scores of Adaptive Behavior Assessment System

  baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

• Changes in accuracy of Frith-Happe animation

  baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

Study Arms (2)

Active

EXPERIMENTAL

Participants received the intervention of iTBS (The total pulse of every session is 1200 pulses) over bilateral posterior superior temporal sulcus 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 iTBS (sham-coil) over bilateral posterior superior temporal sulcus 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 Autism Diagnostic Observation Schedule II (CSS≧6)
• No change in psychiatric drugs within one month

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
• History of brain surgery or nervous system infection, such as meningitis and encephalitis
• Previous febrile seizures
• Concurrent use of medications which increased the risk of seizure attack.
• Participate another clinical trial within one month.
• Unable to complete MRI scan (claustrophobia)
• Skin trauma on application site
• Individuals with a large ischemic scar
• Individuals suffering from multiple sclerosis

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

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: October 11, 2022
• First Posted: October 13, 2022
• Study Start: February 3, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

TW (1)