Clinical trial NCT05254769: Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)
Official title: Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurofeedback
Autistic Disorder
Autism Spectrum Disorder
Neurodevelopmental Disorders
Keywords: Neurofeedback
Autism Spectrum Disorder
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
Collaborators: name: Khyber Medical University Peshawar
First posted: 2022-02-24
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm Pre and Post intervention Design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Childhood Autism Rating Scale (CARS)
timeFrame: Baseline
measure: IQ (Intelligence Quotient) scoring (Colored Progressive Matrices (CPM)
timeFrame: Baseline
measure: Reward sensitivity testing
timeFrame: Baseline
Secondary outcomes:
measure: Changes in Flanker Inhibitory Control and Attention Score
timeFrame: Baseline, at 10 weeks and 18 weeks
measure: Changes in Dimensional Change Card Sort Score; Cognitive Flexibility
timeFrame: Baseline, at 10 weeks and 18 weeks
measure: Changes in List Sorting Working Memory Score
timeFrame: Baseline, at 10 weeks and 18 weeks
measure: Changes in Pattern Comparison Processing Speed Score
timeFrame: Baseline, at 10 weeks and 18 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Federal Medical and Dental College, Shaheed Zulfiqar Ali Bhutto Medical University
Study officials:
affiliation: FM&DC, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, Pakistan
name: Shemaila Saleem
role: PRINCIPAL_INVESTIGATOR
affiliation: Khyber Medical University, Peshawar, Pakistan
name: Hamid Habib
role: PRINCIPAL_INVESTIGATOR
References: