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Completed

NCT Number: NCT03422016

Electroretinogram in Autistic Spectrum Disorders

This study aims to find out the incidence of a reduced light adapted electroretinogram (ERG) b-wave amplitude in children with a diagnosis of Autism Spectrum Disorders (ASD).

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Key information

Age range

4 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Flinders University, Adelaide, South Australia, Australia

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About this study

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition which becomes apparent as children grow. Children with ASD are slow to develop language and have problems interacting socially with others. It is not clear why ASD occurs, but there is some evidence that the signals that tell the brain how to grow are altered which causes the brain to develop and function differently in people with ASD. Eyes develop from the same embryonic tissue as the brain. This means that the retina, which is the light sensitive layer at the back of the eye, shares the same signals as the brain. Investigators can listen to retinal signals outside the eye and the retina can, in this way, act as an accessible part of the brain.

The investigators will detect retinal signals as electrical messages. Sensors placed near the eye pick up the electrical changes in the retina each time a light flashes. This non-invasive, routine clinical test is called an electroretinogram, (ERG). The investigators have carried out a study that showed differences in the ERGs recorded from adults with ASD compared to control participants.

The main aim of this project is find out how common ERG differences are in children with ASD compared to controls. If it is common, investigators could use the ERG to make an earlier diagnosis of ASD and help families sooner. It could help investigators better understand the way the ASD brain signals and give investigators a way of measuring if therapies work.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cohort 1: individuals with diagnosis ASD with an IQ measure exceeding 85
  • cohort 2: typically developed controls without diagnosis of ASD

Exclusion criteria

  • a history of eye disease or treatment or seizure medicines that may alter retinal function

Treatment and study plan

electroretinogram (ERG)

Diagnostic Test

an ERG is a measure of the eyes response to a flash of light

Primary outcomes

  1. light adapted electroretinogram

    Time frame: 12 months

    incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder

Sponsors and collaborators

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Other

Collaborators

  • Flinders University
  • Swinburne University of Technology
  • Yale University

Registry information

Official study title

The Incidence of Altered Light Responses in Children With Autistic Spectrum Disorders

Acronym: ERG in ASD

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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