Neuroregulatory Effect and Mechanism of tDCS on Medial Prefrontal Cortex in ASD
- Conditions
- ASD
- Interventions
- Device: Transcranial direct current stimulation
- Registration Number
- NCT06305988
- Lead Sponsor
- Jian-Jun Ou
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group（Transcranial direct current stimulation） Transcranial direct current stimulation tDCS group participants will receive tDCS intervention stimulation for 1 week (1.5mA, 20min/ time, twice a day) control group（Sham Transcranial direct current stimulation） 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
- Primary Outcome Measures
Name Time Method Autism assessment assessment index 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 Outcome Measures
Name Time Method Social Communication Changes index Baseline, the day after intervention, three weeks after intervention Assessed by the Social Response Scale (SRS-II). The change in social communication scores from baseline to the end of the study period will be the primary outcome of interest, the critical value is 59.5, and the total score is the sum of all entries, with the lowest score of 0 and the highest score of 3 for each entry.
Sensory index Baseline, the day after intervention, three weeks after intervention The Short Sensory Profile (SSP) was used to assess sensory processing abnormalities in children. Each statement has a rating range, which is a 5-point scale from "always" to "never." Raters need to rate the child based on how often they respond to specific sensory inputs. The total score of the SSP is the sum of the scores of all entries. The lowest score generally reflects a higher level of sensory processing difficulty, while the highest score indicates less difficulty.
Sleep index Baseline, the day after intervention,three weeks after intervention Childhood Sleep Disorders Scale (SDSC) was used to assess children's sleep problems and habits. Ratings are usually based on frequency and duration, such as "always," "often," "sometimes," "occasionally," or "never happens." Each entry is typically scored on a scale of 0 to 5, with 0 being no problem and the highest being the most serious. The total score of the CSHQ is the sum of the scores of all entries.
Stereotyped behavior index Baseline, the day after intervention, three weeks after intervention The Repetitive Stereotyping Behavior Scale-Revised (RBS-R) is a tool used to assess repetitive and stereotyping behaviors in autism spectrum disorders (ASD) and other related disorders. The scale consists of 5 subscales, namely Ⅰ stereotypical behavior scale, Ⅱ self-injury behavior scale, Ⅲ impulsive behavior scale, Ⅳ ritualistic behavior scale, Ⅴ fixed behavior scale, and the score is 0= these behaviors have never happened -- 3= these behaviors have happened. And it's serious; The number of positive items is items other than those with a zero score.
EEG physiological detection index Baseline, the day after intervention, three weeks after intervention detect resting state and task state EEG, analyze and calculate the functional E/I ratio of EEG power spectrum
Abnormal behavior indicator Baseline, the day after intervention, three weeks after intervention Individuals are assessed for behavioral abnormalities using the Aberrant Behavior Checklist-Second Edition (ABC-II), a scoring system designed according to the frequency and severity of behavioral problems. For each entry, raters are asked to rate it according to the following criteria: 0: no problem at all. Score 1: The behavior is problematic, but the degree is not serious. Score 2: The problem is moderately serious. 3 marks: The problem is serious. The total score for ABC-II is the sum of scores for all entries, with the lowest score (i.e., all entries are rated 0) indicating that no behavioral problems were observed, while the highest score (i.e., all entries are rated 3) indicating widespread and serious behavioral problems.
Trial Locations
- Locations (1)
Department of Psychiatry, Xiangya Second Hospital, Central South University
🇨🇳Changsha, Hunan, China