Electroretinogram in Autistic Spectrum Disorders

NCT03422016 — Completed, 177 participants, Great Ormond Street Hospital for Children NHS Foundation Trust

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

RegistryNCT03422016, acronym ERG in ASD
StatusCompleted
Study typeObservational
Enrollment177 (Actual)
SponsorGreat Ormond Street Hospital for Children NHS Foundation Trust (Other); collaborators: Flinders University, Yale University, Swinburne University of Technology
ConditionsAutism Spectrum Disorder
Interventionselectroretinogram (ERG) (Diagnostic test)
Datesstart 2018-09-03, primary completion 2020-03-03, completion 2020-04-03, first posted 2018-02-05, last updated 2022-01-11
Locations4 sites in United States, Australia, United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Autism Spectrum Disorder All trials of electroretinogram (ERG)

-Summary

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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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
autistic spectrum disorderDiagnostic Test: electroretinogram (ERG)intelligence quotient IQ>85 age 4-25yrs
controlDiagnostic Test: electroretinogram (ERG)age 4-25yrs no eye disorder
  • electroretinogram (ERG) (Diagnostic test): an ERG is a measure of the eyes response to a flash of light

+Outcome measures

Primary outcomes

  • light adapted electroretinogram [12 months]: incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder

+Eligibility

Sex: All, ages: 4 Years to 25 Years, accepts healthy volunteers

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

+Locations (4)

FacilityCityCountryStatus
Yale UniversityNew Haven, ConnecticutUnited States
Flinders UniversityAdelaide, South AustraliaAustralia
Swinburne University of TechnologyMelbourneAustralia
Great Ormond Street Hospital for Children NHS TrustLondonUnited Kingdom

+Investigators

  • Dorothy A Thompson, PhD, Principal investigator, Consultant Clinical Scientist Visual Electrophysiology, Great Ormond Street Hospital for Children London UK
  • Paul Constable, PhD, Study director, Head Of Teaching Optometry, Flinders Vision Autism Centre, Flinders University, Australia
  • James McPartland, PhD, Principal investigator, Associate Professor of Child Psychiatry and Psychology, Director, Yale Developmental Disabilities Clinic, Yale University, USA