Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that can be delivered in a home setting. It is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with Autism Spectrum Disorder (ASD). Children and youth with ASD will be randomized to At-home tDCS or sham control stimulation for 3 weeks. We will measure the effect of At-home tDCS on the brain mechanisms and clinical measures of social communication and self-regulation..
详细描述
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that can be delivered in a home setting. It is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with Autism Spectrum Disorder (ASD). Previous studies have been limited by small and poorly represented samples, lack of experimental control, insufficient follow-up periods, inadequate blinding and the absence of neural outcome measures. Our project will collect pilot data on the effects of home-based tDCS on reducing disruptive behaviours in youth with ASD, in order to inform the design of a follow-up full-scale clinical trial. We will recruit youth with ASD who experience clinically significant difficulties with social communication and self-regulation. Participants will be randomized to tDCS or sham control stimulation for 3 weeks. We will measure the effect of tDCS on the brain mechanisms and clinical measures of social communication and self-regulation..
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, Care Provider, Outcomes Assessor)
盲法说明
Participants and outcomes assessor will be blind to tDCS or sham condition.
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with a diagnosis of autism spectrum disorder and self-regulation impairment or social communication challenges
- •Able to participate in tDCS
排除标准
- •Children with contraindications to tDCS (history of seizures, family history of seizures, metal implants)
- •Co-existing neurological conditions (epilepsy, stroke, etc.)
结局指标
主要结局
Recruitment
时间窗: weeks 1-18
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Attrition
时间窗: weeks 1-18
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Blinding
时间窗: weeks 1-18
Blinding of participants and their parents/caregivers and required study team using a Blinding Questionnaire indicating the perceived group membershipmembers will be assessed using a Blinding Questionnaire indicating the perceived group membership (tDCS/Sham)
Adherence
时间窗: weeks 1-18
90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)
次要结局
- Inhibitory control(0 weeks, 6 weeks, 18 weeks)
- Magnetic Resonance Imaging (MRI)(0 weeks, 6 weeks, 18 weeks)
- Overall Clinical Change(0 weeks, 6 weeks, 18 weeks)