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

ConditionAutism Spectrum Disorder (ASD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorCentral South University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Active groupActive comparator 1 intervention
Group B: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

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

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

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Central South University

Lead sponsor

Source ClinicalTrials.gov
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