Clinical trial NCT06723522: High Definition Transcranial Direct Current Stimulation of Right Inferior Frontal Gyrus to Improve Social Impairments in Children with Autism
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Keywords: autism
tDCS
social
fNIRS
RCT
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Social function as measured by the Social Responsiveness Scale-2nd Edition(SRS-2)
timeFrame: Social functioning was assessed before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion.
Secondary outcomes:
measure: 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
timeFrame: before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion.
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: