Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

Conditions
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Neurofeedback, Autistic Disorder, Autism Spectrum Disorder, Neurodevelopmental Disorders

Intervention / Treatment
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* Device: Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 7 to 17 year olds (diagnosed by their physician with autism, in accordance with DSM-V (Diagnostic Statistical Manual-V) diagnostic criteria Exclusion Criteria: Any child with a history of Brain injury Bipolar Disorder Tourette's Syndrome Uncontrolled seizure disorder Major psychiatric disorder Children on medications

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm Pre and Post intervention Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback Intervention in children with Autism Spectrum Disorder<br>Neurofeedback therapy will be provided to 35 children with Autism Spectrum Disorder 30 sessions each and cognitive domains will be assessed before and after intervention. | Device: Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.<br>* The EEG NeuroAmp (Electroencephalogram Amplifier) is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP (Event related potential) measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Childhood Autism Rating Scale (CARS) | 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. | Baseline | 
| IQ (Intelligence Quotient) scoring (Colored Progressive Matrices (CPM) | 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. | Baseline | 
| Reward sensitivity testing | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Flanker Inhibitory Control and Attention Score | Flanker Inhibitory Control and Attention Score measures the allocation of one's limited capacities to deal with an abundance of environmental stimulation. It is an assessment of attention and executive Function It will be used to investigate if Neurofeedback therapy affect it and how much. Flanker Inhibitory Control and Attention Score measures the allocation of one's limited capacities to deal with an abundance of environmental stimulation. It is an assessment of attention and executive Function It will be used to investigate if Neurofeedback therapy affect it and to what extent. | Baseline, at 10 weeks and 18 weeks | 
| Changes in Dimensional Change Card Sort Score; Cognitive Flexibility | Dimensional Change Card Sort Score measures the capacity to plan, organize and monitor the execution of behaviours that are strategically directed in a goal-oriented manner. It is also an assessment of executive functions. It will be used to investigate if Neurofeedback therapy affects it and to what extent. | Baseline, at 10 weeks and 18 weeks | 
| Changes in List Sorting Working Memory Score | List Sorting Working Memory Score measures the ability to store information until the amount of information to be stored exceeds one's capacity to hold that information. It is an assessment of working memory It will be used to investigate if Neurofeedback therapy affects it and to what extent. | Baseline, at 10 weeks and 18 weeks | 
| Changes in Pattern Comparison Processing Speed Score | Pattern Comparison Processing Speed Score assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed. It will be used to investigate if Neurofeedback therapy affects it and to what extent. | Baseline, at 10 weeks and 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurofeedback, Autism Spectrum Disorder