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Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

Primary Purpose

Neurofeedback, Autistic Disorder, Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.
Sponsored by
Shaheed Zulfiqar Ali Bhutto Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurofeedback focused on measuring Neurofeedback, Autism Spectrum Disorder

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal Medical and Dental College, Shaheed Zulfiqar Ali Bhutto Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurofeedback Intervention in children with Autism Spectrum Disorder

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 7, 2022
Last Updated
March 4, 2022
Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Collaborators
Khyber Medical University Peshawar
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1. Study Identification

Unique Protocol Identification Number
NCT05254769
Brief Title
Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)
Official Title
Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Collaborators
Khyber Medical University Peshawar

4. Oversight

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

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofeedback, Autistic Disorder, Autism Spectrum Disorder, Neurodevelopmental Disorders
Keywords
Neurofeedback, Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm Pre and Post intervention Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback Intervention in children with Autism Spectrum Disorder
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Childhood Autism Rating Scale (CARS)
Description
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.
Time Frame
Baseline
Title
IQ (Intelligence Quotient) scoring (Colored Progressive Matrices (CPM)
Description
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.
Time Frame
Baseline
Title
Reward sensitivity testing
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Changes in Flanker Inhibitory Control and Attention Score
Description
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.
Time Frame
Baseline, at 10 weeks and 18 weeks
Title
Changes in Dimensional Change Card Sort Score; Cognitive Flexibility
Description
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.
Time Frame
Baseline, at 10 weeks and 18 weeks
Title
Changes in List Sorting Working Memory Score
Description
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.
Time Frame
Baseline, at 10 weeks and 18 weeks
Title
Changes in Pattern Comparison Processing Speed Score
Description
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.
Time Frame
Baseline, at 10 weeks and 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Associate Professor
Phone
0923315106766
Email
drshemailasaleem@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shemaila Saleem
Organizational Affiliation
FM&DC, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, Pakistan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hamid Habib
Organizational Affiliation
Khyber Medical University, Peshawar, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Medical and Dental College, Shaheed Zulfiqar Ali Bhutto Medical University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shemaila Saleem, MPhil, MPH
Phone
0923315106766
Email
drshemailasaleem@gmail.com, shemailasaleem@fmdc.edu.pk
First Name & Middle Initial & Last Name & Degree
Hamid Habib, PhD
Phone
0923335247457
Email
dr.hamidhabib@gmail.com, hamid.habib@kmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Shemaila Saleem, MPhil, MPH
First Name & Middle Initial & Last Name & Degree
Hamid Habib, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

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