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

NCT06723522 · tracked via the Priya Life Science China tracker

Sponsor

Central South University

Phase

Not applicable

Started

2024-08-30

Last updated

2024-12-19

Condition(s) studied

Autism Spectrum Disorder (ASD)

Investigational drug(s) / intervention(s)

HD-tDCSSham (No Treatment)

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

Study 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.

Eligibility

Sex

ALL

Min age

3 Years

Max age

18 Years

Healthy volunteers

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).

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
The Second Xiangya Hospital of Central South University	Changsha	Hunan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06723522 on ClinicalTrials.gov ↗ ← All trials in China