Comparable Efficacy of Transcranial Direct Current Stimulation and Pharmacological Treatments in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Gilliam Autism Rating Scale (GADS)
研究概览
简要总结
This project aims to comparing the effectiveness of transcranial direct current stimulation with common pharmacological treatments on behavioral problems and cognitive deficits of children with autism spectrum disorder
详细描述
45 children with autism spectrum disorder are recruited in Fatemi Hospital at Ardabil University of Medical Sciences. The patients will be randomized into 3 Intervention groups of 15 with tDCS stimulation, risperidone, and placebo medication as the interventions. The study will be a randomized double-blind controlled design. The experimenter and the patient are blinded and are not aware of the study. Intervention group 1: TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the F3 and cathodal electrode will be placed over the Fp2. They will also receive a placebo tablet (Galenus pharmaceutical company) in each stimulation session. Intervention group 2: Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days. Intervention group 3: Participants in this group undergo 10 daily sessions of sham tDCS concurrent with a placebo tablet (Galenus pharmaceutical company) for 10 consecutive days.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of autism spectrum disorder by a psychiatrist and behavioral checklist
- •being 6-16 years old
- •providing written informed consent signed by parents
排除标准
- •comorbidity with other neurodevelopmental disorders
- •comorbidity with other neurological disorders
- •previous history of neurosurgery
- •presence of any ferromagnetic metal in the head
- •implanted medical devices in the head or neck region
- •history of noncontrolled epilepsy with seizures in the last year
研究组 & 干预措施
tDCS group
TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the left dorsolateral prefrontal cortex and cathodal electrode will be placed over the right supraorbital area.
干预措施: transcranial direct current stimulation (Device)
tDCS group
TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the left dorsolateral prefrontal cortex and cathodal electrode will be placed over the right supraorbital area.
干预措施: Placebo (Drug)
Medication group
Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
干预措施: RisperiDONE 1 MG/ML (Drug)
Medication group
Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
干预措施: sham transcranial direct current stimulation (Device)
Control group
Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days.
干预措施: Placebo (Drug)
Control group
Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days.
干预措施: sham transcranial direct current stimulation (Device)
结局指标
主要结局
Gilliam Autism Rating Scale (GADS)
时间窗: up to 3 months after the intervention
Score in the Gilliam Autism Rating Scale (GADS) Autism index scores: 69 or less = unlikely 70-84 = possible 85 or higher = very likely
Theory of mind
时间窗: up to 3 months after the intervention
Score in the Theory of Mind Test (ToMT) Score range of subscales 1 to 3, is 0-20, 0-13, and 0-5, respectively and the total score range is 0-38.
verbal fluency task
时间窗: up to 3 months after the intervention
Performance in the verbal fluency task as an executive and language function task
次要结局
未报告次要终点
研究者
Mohammad Ali Salehinejad
Principal Investigator
The National Brain Mapping Laboratory (NBML)