Department of Psychiatry, Xiangya Second Hospital, Central South University
Changsha, Hunan, 410000, China
NCT Number: NCT06305988
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.
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Notify Me4 year–18 year
All sexes
Interventional
Not applicable
Changsha, Hunan, 410000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, the day after intervention, three weeks after intervention
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline, the first day of intervention
The levels of metabolites in plasma will be detected and quantified using a comprehensive Metabolomics detection approach. This method involves analyzing small-molecule chemical compounds found in plasma, providing a broad snapshot of the metabolic state of an organism at the given time points.
Time frame: Baseline, the day after intervention, three weeks after intervention
The scale is the most commonly used safety assessment tool in clinical trials to assess whether participants had side effects or sudden adverse events during the course of the study. The SAFTEE-GI (General inquiry) version was adopted in this study, which asked subjects in detail whether they had physical or psychological problems, occurrence time, duration, frequency and status quo during a specific period of time, so as to timely discover the adverse reactions of subjects during the clinical trial. Discontinue the study if adverse events occur.
Jian-Jun Ou
Other
Neuroregulatory Effect and Mechanism of Transcranial Direct Current Stimulation on Medial Prefrontal Cortex in Autism Spectrum Disorder
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