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

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder (ASD)

• Registration Number: NCT06723522

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Social function as measured by the Social Responsiveness Scale-2nd Edition(SRS-2)	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China