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

Central South University

Status: Enrolling

Conditions: Autism Spectrum Disorder (ASD)

Treatments: Device: Sham (No Treatment); Device: HD-tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06723522

LYEC2024-0306

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Active group

Active Comparator group

Description:

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.

Treatment:

Device: HD-tDCS

Sham group

Sham Comparator group

Description:

Received 1 min of ramping up/down without experiencing 2 mA HD-tDCS stimulation lasted for 20 min.

Treatment:

Device: Sham (No Treatment)