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

December 17, 2024 updated by: Xuerong Luo, Central South University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active group
Received a dose of 2 mA HD-tDCS stimulation lasted for 20 min, with 30 s of ramp-up and ramp-down before and after the 20-min stimulation, respectively.
Device: 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 Comparator: Sham group
Received 1 min of ramping up/down without experiencing 2 mA HD-tDCS stimulation lasted for 20 min.
Device: Sham (No Treatment)
Received 1 min of ramping up/down without experiencing 2 mA HD-tDCS stimulation lasted for 20 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Social functioning was assessed before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYEC2024-0306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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