Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

Autism Spectrum Disorder Clinical Trial

Official title:

Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254769
• Other study ID #: NFB
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: May 2022

Study information

• Verified date: March 2022
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: Associate Professor
• Phone: 0923315106766
• Email: drshemailasaleem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: May 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease
• Neurodevelopmental Disorders
• Neurofeedback

Intervention

Device:
• Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.
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.

Locations

Country	Name	City	State
Pakistan	Federal Medical and Dental College, Shaheed Zulfiqar Ali Bhutto Medical University	Islamabad

Sponsors (2)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University	Khyber Medical University Peshawar

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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