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Clinical Trials/NCT05254769
NCT05254769
Unknown
N/A

Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)

Shaheed Zulfiqar Ali Bhutto Medical University1 site in 1 country35 target enrollmentNovember 15, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neurofeedback
Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Enrollment
35
Locations
1
Primary Endpoint
Childhood Autism Rating Scale (CARS)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2021
End Date
May 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Shemaila Saleem

Associate Professor

Shaheed Zulfiqar Ali Bhutto Medical University

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Changes in Dimensional Change Card Sort Score; Cognitive Flexibility(Baseline, at 10 weeks and 18 weeks)
  • Changes in Pattern Comparison Processing Speed Score(Baseline, at 10 weeks and 18 weeks)
  • Changes in Flanker Inhibitory Control and Attention Score(Baseline, at 10 weeks and 18 weeks)
  • Changes in List Sorting Working Memory Score(Baseline, at 10 weeks and 18 weeks)

Study Sites (1)

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