NCT05254769

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

February 7, 2022

Last Update Submit

March 4, 2022

Conditions

NeurofeedbackAutistic DisorderAutism Spectrum DisorderNeurodevelopmental Disorders

Keywords

NeurofeedbackAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline

  • 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.

    Baseline

  • 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.

    Baseline

Secondary Outcomes (4)

  • Changes in Flanker Inhibitory Control and Attention Score

    Baseline, at 10 weeks and 18 weeks

  • Changes in Dimensional Change Card Sort Score; Cognitive Flexibility

    Baseline, at 10 weeks and 18 weeks

  • Changes in List Sorting Working Memory Score

    Baseline, at 10 weeks and 18 weeks

  • Changes in Pattern Comparison Processing Speed Score

    Baseline, at 10 weeks and 18 weeks

Study Arms (1)

Neurofeedback Intervention in children with Autism Spectrum Disorder

EXPERIMENTAL

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.

Interventions

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

Neurofeedback Intervention in children with Autism Spectrum Disorder

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 17 year olds (diagnosed by their physician with autism, in accordance with DSM-V (Diagnostic Statistical Manual-V) diagnostic criteria

You may not qualify if:

  • Brain injury
  • Bipolar Disorder
  • Tourette's Syndrome
  • Uncontrolled seizure disorder
  • Major psychiatric disorder
  • Children on medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveMental Disorders

Study Officials

  • Shemaila Saleem

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

    PRINCIPAL INVESTIGATOR

  • Hamid Habib

    Khyber Medical University, Peshawar, Pakistan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Associate Professor

CONTACT

0923315106766drshemailasaleem@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm Pre and Post intervention Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 24, 2022

Study Start

November 15, 2021

Primary Completion

March 1, 2022

Study Completion

May 1, 2022

Last Updated

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)