Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

March 4, 2022 updated by: Dr. Shemaila Saleem, Shaheed Zulfiqar Ali Bhutto Medical University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Flanker Inhibitory Control and Attention Score
Time Frame: Baseline, at 10 weeks and 18 weeks
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
Time Frame: Baseline, at 10 weeks and 18 weeks

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
Time Frame: Baseline, at 10 weeks and 18 weeks
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
Time Frame: Baseline, at 10 weeks and 18 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Collaborators

Khyber Medical University Peshawar

Investigators

  • Principal Investigator: Shemaila Saleem, FM&DC, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, Pakistan
  • Principal Investigator: Hamid Habib, Khyber Medical University, Peshawar, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2021

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (ACTUAL)

February 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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