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

NCT06723522 | Recruiting DMC

• 1 other identifier: LYEC2024-0306
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder (ASD)

Keywords

autism; tDCS; social; fNIRS; RCT

Outcome Measures

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.

  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

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

Study Arms (2)

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.

Device: HD-tDCS

Sham group

SHAM COMPARATOR

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

Device: Sham (No Treatment)

Interventions

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.

Active group

Sham (No Treatment) DEVICE

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

Sham group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Xuerong Luo, Doctor

CONTACT

+86 731 85296820; luoxuerong@csu.edu.cn

Shuxian Wu, Doctor

CONTACT

+86 15776577926; wushuxian@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 9, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)