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NCT Number: NCT06723522

High Definition Transcranial Direct Current Stimulation of Right Inferior Frontal Gyrus to Improve Social Impairments in Children with Autism

The goal of this clinical trial is to learn if high definition transcranial direct current stimulation (HD-tDCS) of right inferior frontal gyrus works to improve social impairments in children with autism spectrum disorder (ASD). It will also learn about the underlying brain mechanism. The main questions it aims to answer are:

* Does HD-tDCS of right inferior frontal gyrus improve social impairments in children with ASD? * What are the underlying brain mechanisms by which the HD-tDCS of right inferior frontal gyrus improves social impairments in children with ASD? Researchers will compare participants received active HD-tDCS to controls received sham HD-tDCS (performed to mimic the sensation induced by real HD-tDCS before and after the stimulation) to see if HD-tDCS of right inferior frontal gyrus improves social impairments in children with ASD.

Participants will:

* Receive a dose of 2 mA HD-tDCS of right inferior frontal gyrus lasting for 10 days. * Receive social functioning assessment, functional near-infrared spectroscopy and electroencephalography measurement before and after stimulation * Visit the clinic once every 2 weeks for checkups and tests, a total of 2 times.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location status: Recruiting

Location contact

Shuxian Wu

CONTACT

[email protected]

13760412599

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • had to be 3-18 years old; be diagnosed with ASD (according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and Autism Diagnostic Interview - Revised (ADI-R).

Exclusion criteria

  • with other comorbid neuropsychiatric conditions (i.e., schizophrenia spectrum disorders and mood disorders) or neurological disorders (i.e., head trauma and epilepsy).

Treatment and study plan

HD-tDCS

Device

2 mA HD-tDCS of right inferior frontal gyrus lasting for 10 days, each stimulation lasted for 20 min, with 30 s of ramp-up and ramp-down before and after the 20-min stimulation, respectively.

Sham (No Treatment)

Device

Received 1 min of ramping up/down without experiencing 2 mA HD-tDCS stimulation lasted for 20 min.

Primary outcomes

  1. Social function as measured by the Social Responsiveness Scale-2nd Edition(SRS-2)

    Time frame: Social functioning was assessed before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion.

    SRS-2 is a highly reliable and sensitive scale to measure social function in RCTs involving individuals with autism.

Secondary outcomes

  1. The resting-state functional connectivity between the right inferior frontal gyrus and other brain regions involving social function as measured by functional near-infrared spectroscopy

    Time frame: before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion.

    Functional changes in individuals with autism have been found to be associated with social impairment in these individuals. Functional near-infrared spectroscopy (fNIRS) is a non-invasive, portable and body-motion tolerant neuroimaging technique that has been used to measure changes in functional connectivity between different brain networks.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuxian Wu, Doctor

CONTACT

[email protected]

+86 15776577926

Xuerong Luo, Doctor

CONTACT

[email protected]

+86 731 85296820

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

The Efficacy and Brain Mechanism of High Definition Transcranial Direct Current Stimulation of Right Inferior Frontal Gyrus to Improve Social Impairments in Children with Autism Spectrum Disorder: a Randomized, Double-blind, Controlled Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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