Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Childhood Autism Rating Scale (CARS)
研究概览
简要总结
This project aims to:
- explore the effectiveness of Neurofeedback therapy for children diagnosed with Autism Spectrum Disorder (ASD)
- assess if cognitive functions are affected before and after Neurofeedback Intervention
详细描述
Neurofeedback is a computer assisted programmed technique that functions by tracing brain electrical activity (EEG) and providing feedback about the brain activity and sends visual and acoustic signals to counter the mismatch in the electrical activity for improvement. It is a course of learning that allows the patient to observe, regulate and modify his/her own brain activity. Neurofeedback will be carried out in 35 children with Autism Spectrum Disorder (ASD) over a 30-session training period to improve the cognitive functions. This study aims to improve the behavioural and cognitive functions of children and adolescents with Neurofeedback therapy. As Neurofeedback therapy is a non-invasive treatment with almost no side effects, this study will contribute to practice of effective and scalable assessment and treatment strategy for children and adolescents with ASD, utilizing objective tools that have not widely been used in the assessment of Cognitive functions for ASD.
Goal is to improve the quality of life of children on the spectrum by enabling them to perform day to day activities of life and to improve their social communication. Moreover, this study seeks to be a contribution for creating mass awareness regarding the efficacy of Neurofeedback therapy especially in the developing world. Hopefully in the future Neurofeedback training would be incorporated as a standard of care for ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7 to 17 year olds (diagnosed by their physician with autism, in accordance with DSM-V (Diagnostic Statistical Manual-V) diagnostic criteria
排除标准
- •Any child with a history of
- •Brain injury
- •Bipolar Disorder
- •Tourette's Syndrome
- •Uncontrolled seizure disorder
- •Major psychiatric disorder
- •Children on medications
结局指标
主要结局
Childhood Autism Rating Scale (CARS)
时间窗: Baseline
Childhood Autism Rating Scale (CARS) is designed as a clinical rating scale for trained clinician to rate items indicative of Autism Spectrum Disorder (ASD) after direct observation of child.The form is used with individuals of all ages and in both clinical and research settings.
IQ (Intelligence Quotient) scoring (Colored Progressive Matrices (CPM)
时间窗: Baseline
Tests have been designed to measure as unambiguously as possible, educative and reproductive abilities. It is designed for use with young children and old people, or for those with poor language skills for whatever reason.
Reward sensitivity testing
时间窗: Baseline
Neurofeedback is an operant conditioning so the responsiveness and non- responsiveness of the subjects can be attributed to the reward sensitivity. Reward sensitivity for children and adolescents with autism will be assessed by Reward Responsiveness Scale.
次要结局
- Changes in Dimensional Change Card Sort Score; Cognitive Flexibility(Baseline, at 10 weeks and 18 weeks)
- Changes in Pattern Comparison Processing Speed Score(Baseline, at 10 weeks and 18 weeks)
- Changes in Flanker Inhibitory Control and Attention Score(Baseline, at 10 weeks and 18 weeks)
- Changes in List Sorting Working Memory Score(Baseline, at 10 weeks and 18 weeks)
研究者
Dr. Shemaila Saleem
Associate Professor
Shaheed Zulfiqar Ali Bhutto Medical University