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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Active Comparator | 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. |
|
| Sham group | Sham Comparator | Received 1 min of ramping up/down without experiencing 2 mA HD-tDCS stimulation lasted for 20 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Social functioning was assessed before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion. |
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuerong Luo, Doctor | Contact | +86 731 85296820 | luoxuerong@csu.edu.cn | |
| Shuxian Wu, Doctor | Contact | +86 15776577926 | wushuxian@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
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| Sham (No Treatment) | Device | Received 1 min of ramping up/down without experiencing 2 mA HD-tDCS stimulation lasted for 20 min. |
|
| before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion. |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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