Transcranial Direct Current Stimulation (tDCS) as an add on treatment for Restricted Repetitive Behaviour Domain of Autism Spectrum Disorder - an open label prospective study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Reduction in Restricted repetitive behaviourseverity as measured on the Repetitive behaviour scale- revised
研究概览
简要总结
Repetitive Restricted Behaviours(RRB) are an important clinical component of Autism spectrum disorder(ASD) and cause significant dysfunction in personal, social and occupational domains. Antipsychotic medications such as Risperidone and Aripiprazole though have some evidence for treatment; are however associated with adverse effects. Trancranial direct current stimulation(tDCS) is a safe intervention strategy with minimal side effects such as transient skin burning and has evidence of safety in children with ASD. On this background, the current study will be an open-labelled study evaluating the efficacy of anodal stimulation of left dorsolateral prefrontal cortex and cathodal stimulation of the supplementary motor area to target the higher-order as well as lower-order RRBs. Informed consent would be obtained from the parents and assent from adolescents older than 12 years of age. Adolescents in the age group of 10-18 years with ASD and dysfunctional RRBs will be recruited. The sessions would be carried out over a period of 5 working days with twice-a-day sessions of 20 minutes each and with an inter-session interval of 20 minutes. A current of 2mA will be administered. Baseline and follow-up assessments will include measures of RRB severity(Repetitive behaviour scale-revised), Autism treatment evaluation checklist, Developmental Disabilities modification of Children’s Global Assessment Scale(DD-CGAS), and Behavior Rating Inventory of Executive Function- parent version(BRIEF scale) to understand a mediator role of executive dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 10.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of Autism spectrum disorder (DSM-5) and confirmed by INCLEN diagnostic tool;
- •Age 10-18 years;
- •Having clinically significant Restricted and repetitive behaviours, causing functional impairment; 5.Written informed consent of parents and informed assent from adolescents (>12 years).
排除标准
- •1.Uncontrolled Seizure disorder/ Severe neurological illness/ structural brain disease; 2.Suicidal risk / any psychiatric emergency; 3.Exclusion of obsessive-compulsive disorder as aetiology for repetitive behaviours- via clinical evaluation. 4.Clinical diagnosis of severe.
- •profound intellectual disability; 5.Acute mood / psychotic disorder (As RRBs could worsen during a symptomatic phase of comorbid psychiatric disorder); 6.Patients who are uncooperative for treatment due to aggression or severe behavioural issues. 7.Any Contraindication for Transcranial Direct Current Stimulation such as broken or abnormal skin at the site of electrode application, holes in the skull from trauma or surgery.
结局指标
主要结局
Reduction in Restricted repetitive behaviourseverity as measured on the Repetitive behaviour scale- revised
时间窗: Baseline, 2 weeks, 6 weeks, 13 weeks
次要结局
- Improvement in executive functioning as a mediator of improvement in RRBs(Baseline BRIEF tool assessment, followed by 2 weeks, 6 weeks & 13 weeks)