Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

NCT ID: NCT05254769

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-05-31

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.

Conditions

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Neurofeedback Autistic Disorder Autism Spectrum Disorder Neurodevelopmental Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm Pre and Post intervention Design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neurofeedback Intervention in children with Autism Spectrum Disorder

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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

* Brain injury
* Bipolar Disorder
* Tourette's Syndrome
* Uncontrolled seizure disorder
* Major psychiatric disorder
* Children on medications
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khyber Medical University Peshawar

OTHER

Sponsor Role collaborator

Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Shemaila Saleem

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shemaila Saleem

Role: PRINCIPAL_INVESTIGATOR

FM&DC, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, Pakistan

Hamid Habib

Role: PRINCIPAL_INVESTIGATOR

Khyber Medical University, Peshawar, Pakistan

Locations

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Federal Medical and Dental College, Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Associate Professor

Role: CONTACT

0923315106766

Facility Contacts

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Shemaila Saleem, MPhil, MPH

Role: primary

Hamid Habib, PhD

Role: backup

Other Identifiers

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NFB

Identifier Type: -

Identifier Source: org_study_id

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