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

Jian-Jun Ou

Status: Completed

Conditions: ASD

Treatments: Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06305988

LYG2023021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

intervention group（Transcranial direct current stimulation）

Experimental group

Description:

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

Treatment:

Device: Transcranial direct current stimulation

control group（Sham Transcranial direct current stimulation）

Placebo Comparator group

Description:

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

Treatment:

Device: Transcranial direct current stimulation