Neuroregulatory Effect and Mechanism of Transcranial Direct Current Stimulation on Medial Prefrontal Cortex in Autism Spectrum Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Autism assessment assessment index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 4-18 years old;
- •Clinically diagnosed by a psychiatrist with autism spectrum disorder;
- •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;
- •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;
- •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.
Arms & Interventions
intervention group（Transcranial direct current stimulation）
tDCS group participants will receive tDCS intervention stimulation for 1 week (1.5mA, 20min/ time, twice a day)
Intervention: Transcranial direct current stimulation (Device)
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
Intervention: Transcranial direct current stimulation (Device)
Outcomes
Primary Outcomes
Autism assessment assessment index
Time Frame: Baseline, the day after intervention, three weeks after intervention
3\. Autism was assessed using the Oregon State University Autism Rating Scale, DSM-5 (OARS-5), which includes the signs and symptoms of autism spectrum disorders described in the DSM-5. The scores include :1; Total number of symptoms. Every symptom that occurs (i.e., 1, 2, or 3 points) is recorded in the symptom count. 2. Weighted average severity. The clinician scored each item on a scale of 0, 1, 2 or 3 based on the parent's description of the particular problem. 3. Damage index. In Section C of OARS-5, after discussion with the child/adolescent's caregiver, the clinician will rate the level of support on a scale of 0(no support) to 3(maximum support).
Secondary Outcomes
- Social Communication Changes index(Baseline, the day after intervention, three weeks after intervention)
- Sensory index(Baseline, the day after intervention, three weeks after intervention)
- Sleep index(Baseline, the day after intervention,three weeks after intervention)
- Stereotyped behavior index(Baseline, the day after intervention, three weeks after intervention)
- EEG physiological detection index(Baseline, the day after intervention, three weeks after intervention)
- Abnormal behavior indicator(Baseline, the day after intervention, three weeks after intervention)
Investigators
Jian-Jun Ou
Principal Investigator
Central South University