Clinical trial NCT06305988: Neuroregulatory Effect and Mechanism of tDCS on Medial Prefrontal Cortex in ASD
Official title: Neuroregulatory Effect and Mechanism of Transcranial Direct Current Stimulation on Medial Prefrontal Cortex in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ASD
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Autism assessment assessment index
timeFrame: Baseline, the day after intervention, three weeks after intervention
Secondary outcomes:
measure: EEG physiological detection index
timeFrame: Baseline, the day after intervention, three weeks after intervention
measure: Social Communication Changes index
timeFrame: Baseline, the day after intervention, three weeks after intervention
measure: Stereotyped behavior index
timeFrame: Baseline, the day after intervention, three weeks after intervention
measure: Sensory index
timeFrame: Baseline, the day after intervention, three weeks after intervention
measure: Abnormal behavior indicator
timeFrame: Baseline, the day after intervention, three weeks after intervention
measure: Sleep index
timeFrame: Baseline, the day after intervention,three weeks after intervention
Other outcomes:
measure: Plasma Metabolite Levels Assessment
timeFrame: At baseline, the first day of intervention
measure: Safety evaluation SAFTEE indicator
timeFrame: Baseline, the day after intervention, three weeks after intervention
Locations:
city: Changsha
country: China
facility: Department of Psychiatry, Xiangya Second Hospital, Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Jianjun Ou, doctor
role: STUDY_CHAIR
affiliation: Central South University
name: Yanting Hou, doctor
role: STUDY_DIRECTOR
References: