Neuroregulatory Effect and Mechanism of tDCS on Medial Prefrontal Cortex in ASD

NCT ID: NCT06305988

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-05-31

Brief Summary

In this proposed study, a transcranial direct current stimulator is used to intervene in the medial prefrontal cortex of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed.

Detailed Description

This is a randomized controlled double-blind trial. Using a transcranial direct current stimulator to stimulate the Autism Spectrum Disorders of children with autism, place an anode patch on Fz and a cathode patch on right cheek to observe whether it can improve social and cognitive function in autism. Parameter settings: The current size is 1.5mA. Treat twice a day for 20 minutes, for a total of 7 days.

Conditions

ASD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention group（Transcranial direct current stimulation）

tDCS group participants will receive tDCS intervention stimulation for 1 week (1.5mA, 20min/ time, twice a day)

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

The anode patch is placed in Fz, and the cathode patch is placed on right cheek, powered by direct current with a current of 1.5mA. Subjects in the placebo comparator group will receive sham tDCS for 1 week, which mimics the tDCS intervention in terms of electrode placement and session frequency. However, the device will deliver a 0mA current, ensuring no actual stimulation occurs. The anode patch is placed at Fz, and the cathode patch is positioned on the right cheek, to maintain the blinding of the intervention.

control group（Sham Transcranial direct current stimulation）

Placebo comparator group subjects will receive similar sites and the same frequency of spurials (0mA, 20min/ time, twice daily) for 1 week

Group Type: PLACEBO_COMPARATOR

Transcranial direct current stimulation

Intervention Type: DEVICE

The anode patch is placed in Fz, and the cathode patch is placed on right cheek, powered by direct current with a current of 1.5mA. Subjects in the placebo comparator group will receive sham tDCS for 1 week, which mimics the tDCS intervention in terms of electrode placement and session frequency. However, the device will deliver a 0mA current, ensuring no actual stimulation occurs. The anode patch is placed at Fz, and the cathode patch is positioned on the right cheek, to maintain the blinding of the intervention.

Interventions

Transcranial direct current stimulation

The anode patch is placed in Fz, and the cathode patch is placed on right cheek, powered by direct current with a current of 1.5mA. Subjects in the placebo comparator group will receive sham tDCS for 1 week, which mimics the tDCS intervention in terms of electrode placement and session frequency. However, the device will deliver a 0mA current, ensuring no actual stimulation occurs. The anode patch is placed at Fz, and the cathode patch is positioned on the right cheek, to maintain the blinding of the intervention.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 4-18 years old;

2. Clinically diagnosed by a psychiatrist with autism spectrum disorder;

3. Confirmed by researchers (pediatric psychiatrists) that they meet the diagnostic criteria for autism spectrum disorders in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) of the United States;

4. Evaluated by researchers (pediatric psychiatrists) using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS), it is consistent with the diagnosis of autism spectrum disorders;

5. Capable of cooperating with magnetic resonance spectroscopy and transcranial direct current stimulation.

Exclusion Criteria

• a) Existence of serious physical diseases and conditions, such as significant intracranial lesions, thyroid diseases, epilepsy, congenital heart disease, severe hematological diseases, systemic lupus erythematosus, visual and auditory impairments, etc;

b) Imaging examination showed significant brain structural abnormalities;

c) Having serious neurological diseases, a clear family history, or potential risks;

d) Metal or pacemaker implantation in the body, holes or cracks in the skull;

e) Taking benzodiazepines or anticonvulsants;

f) The existence of clear or suspicious genetic diseases;

g) Conforming to the diagnosis of other serious mental illnesses, such as schizophrenia and bipolar disorder.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jian-Jun Ou

OTHER

Sponsor Role: lead

Responsible Party

Jian-Jun Ou

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jianjun Ou, doctor

Role: STUDY_CHAIR

Central South University

Yanting Hou, doctor

Role: STUDY_DIRECTOR

Central South University

Locations

Department of Psychiatry, Xiangya Second Hospital, Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

LYG2023021

Identifier Type: -

Identifier Source: org_study_id