The Therapeutic Effects of Continuous Theta Burst Stimulation in Autism Spectrum Disorder

NCT04993144 | Unknown

• 1 other identifier: 201802246A0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator would like to investigate the impact of theta burst stimulation over left dorsolateral prefrontal cortex 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 (8 weeks after baseline); One month follow up (4 weeks after post TBS)

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

Secondary Outcomes (12)

• Changes of total scores of Emotional Dysregulation Inventory

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

• Changes of total scores of Adaptive Behavior Assessment System

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

• Changes of total scores of Vineland Adaptive Behavior Scales

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

• Changes in accuracy of Frith-Happe animation

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

• Changes in accuracy of Eyes task

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

Study Arms (3)

Active

ACTIVE COMPARATOR

Participants received the real intervention of TBS (cTBS 600) over the left dorsolateral prefrontal cortex for 8 weeks (2 days/week). \*cTBS = continuous theta burst stimulation

Device: continuous theta burst stimulation

Sham

SHAM COMPARATOR

Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the left dorsolateral prefrontal cortex for 8 weeks (2 days/week).

Device: continuous theta burst stimulation

Normal control

NO INTERVENTION

No intervention.

Interventions

continuous theta burst stimulation DEVICE

stimulatory protocol

Active; Sham

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• autism spectrum disorder, confirmed by ADOS

You may not qualify if:

• current and past systemic disease
• current and past major psychiatric disorders including schizophrenia, bipolar affective disorder and major depressive disorder
• current and past brain injuries
• intelligence \< 70
• seizure history
• pregnant

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, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 6, 2021
• Study Start: December 10, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

TW (1)