High Definition Transcranial Direct Current Stimulation of Right Inferior Frontal Gyrus to Improve Social Impairments in Children with Autism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HD-tDCS, Sham (No Treatment).
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder (ASD). Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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. - Device Sham (No Treatment)
Received 1 min of ramping up/down without experiencing 2 mA HD-tDCS stimulation lasted for 20 min.
Primary outcome measures
- 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.]
Secondary outcome measures (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 [Time frame: before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion.]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT06723522 · LYEC2024-0306