MedDataX Logo

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

NCT ID: NCT06723522

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder (ASD)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

autism tDCS social fNIRS RCT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active group

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.

Group Type ACTIVE_COMPARATOR

HD-tDCS

Intervention Type 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.

Sham group

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

Group Type SHAM_COMPARATOR

Sham (No Treatment)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Sham (No Treatment)

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central South University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xuerong Luo

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xuerong Luo, Doctor

Role: CONTACT

Phone: +86 731 85296820

Email: [email protected]

Shuxian Wu, Doctor

Role: CONTACT

Phone: +86 15776577926

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shuxian Wu

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LYEC2024-0306

Identifier Type: -

Identifier Source: org_study_id