NCT05254769

Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Neurofeedback
• Autistic Disorder
• Autism Spectrum Disorder
• Neurodevelopmental Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-03-01
• Completion: 2022-05-01
• First posted: 2022-02-24
• Last updated: 2022-03-08

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated device study