Understanding and Targeting Repetitive Behaviors and Restricted Interests in Autism Spectrum Disorder Via High-Definition Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Repetitive Behavior Scale-Revised
研究概览
简要总结
Repetitive behaviors (RBs) are a prevalent feature of Autism Spectrum Disorder (ASD). There are two groups of RBs: lower-order (e.g. motor stereotypies) and higher-order RBs (e.g. restricted interests), linked to sensory-motor and the associative loops, respectively. To date, treatment options for RBs are very limited. High-definition transcranial direct current stimulation (HD-tDCS) may be effective in reducing the impact of RBs in children with ASD by targeting the associated brain alterations. Moreover, the high focality of HD-tDCS will help the investigators to disentangle the relative contribution of different brain loops (namely, sensory-motor and the associative loops) into RBs subtypes. The investigators will also study the electrophysiological patterns associated to behavioral changes after the application of HD-tDCS.
详细描述
The experimental design will be the following: randomized, three-arm, between subject, double blind, and placebo-controlled.
Children and adolescents with ASD will be selected and randomly assigned to three groups: 1. Active high-definition tDCS (HD-tDCS) over pre-SMA; 2. Active high-definition tDCS (HD-tDCS) left DLPFC; 3. Sham high-definition tDCS (HD-tDCS).
In this project, the investigators will work to understand whether a brain-based intervention, with the use of HD-tDCS can enhance RBs in individuals with ASD.
The protocol will allow the investigators to:
- Test if Active high-definition tDCS (HD-tDCS) compared to sham HD-tDCS will contribute in reducing RBs
- Test if HD-tDCS over pre-SMA cortex will decrease lower-order RBs, while HD-tDCS over dlPFC will decrease higher-order RBs
- Test if the Active Groups will significantly improve in the remaining psychological measures compared to the Sham Group
- Test if the Active Groups will change in the RBS-R total score will be significantly correlated with changes in neuropsychological and electroencephalographic (EEG) connectivity measures
- Test if the Active Groups will change in the RBS-R total score will be significantly correlated with changes in the remaining psychological measures and parental stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants of both genders with ASD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and based on clinical evaluation and administration of gold standard tools for ASD diagnosis
- •an intelligence quotient (IQ) higher or equal to 70 (IQ ≥ 70)
- •age range from 8 years to 13 years and 11 months included
排除标准
- •the presence of neurological/medical/genetic conditions (i.e., brain tumours or genetic syndromes)
- •personal or family history of epilepsy
- •other primary psychiatric diagnoses (i.e., bipolar disorders, schizophrenia spectrum disorders, or adjustment disorder)
- •sensorimotor deficits
- •the presence of peacemaker or other metal devices in the body;
- •ongoing CNS-active drug treatment
- •receiving other cognitive-behavioral therapies specifically focused on RBs in the 3 months before the study
结局指标
主要结局
Repetitive Behavior Scale-Revised
时间窗: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
The primary outcome measure will be the Total Score of the Repetitive Behavior Scale-Revised (Bodfish, 2000). It consists of a 43-item parent-report questionnaire evaluating the extent of RBs in individuals with ASD. The tool encompasses six scales: Stereotyped Behavior (6 items), Self-injurious Behavior (8 items), Compulsive Behavior (8 items), Routine Behavior (6 items), Sameness Behavior (11 items), and Restricted Behavior (4 items). The items are rated on a four-point scale (0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem); an overall total raw score and a total number of items score for each subscale are computed. Higher scores indicate greater severity of repetitive behaviors. The sum of all items provides a total raw score ranging from 0 to 129, with higher scores indicating more severe repetitive behaviors.
次要结局
- Wisconsin Card Sorting Test(Baseline, pre-intervention; immediately after the intervention; three-month follow-up.)
- Stop Signal Task(Baseline, pre-intervention; immediately after the intervention; three-month follow-up.)
- Short Sensory Profile 2(Baseline, pre-intervention; immediately after the intervention; three-month follow-up.)
- Behavior Rating Inventory of Executive Function - Second Edition/ parent report(Baseline, pre-intervention; immediately after the intervention; three-month follow-up.)
- Sleep Disturbance Scale for Children(Baseline, pre-intervention; immediately after the intervention; three-month follow-up.)
- Child Behaviour Checklis/ 6-18(Baseline, pre-intervention; immediately after the intervention; three-month follow-up.)
- Childhood Autism Rating Scale-2(Baseline, pre-intervention; immediately after the intervention; three-month follow-up.)
- Parenting Stress Index Short Form(Baseline, pre-intervention; immediately after the intervention; three-month follow-up.)
- Electroencephalography (HD-EEG)(Baseline, pre-intervention and immediately after the intervention.)