Electroretinogram in Autistic Spectrum Disorders (ERG in ASD)

The Incidence of Altered Light Responses in Children With 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).

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Diagnostic test: electroretinogram (ERG)

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.

• Study Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Swinburne University of Technology
  • South Australia
    • Adelaide, South Australia, Australia
      • Flinders University
• United Kingdom
  • London, United Kingdom, WC1N 3JH
    • Great Ormond Street Hospital for Children NHS Trust
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

individuals diagnosed with ASD and typically developing controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
autistic spectrum disorder; intelligence quotient IQ>85 age 4-25yrs	Diagnostic test: electroretinogram (ERG); an ERG is a measure of the eyes response to a flash of light
control; age 4-25yrs no eye disorder	Diagnostic test: electroretinogram (ERG); an ERG is a measure of the eyes response to a flash of light

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
light adapted electroretinogram	incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder	12 months

Collaborators and Investigators

• Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
• Collaborators: Yale University; Flinders University; Swinburne University of Technology
• Investigators: Principal Investigator: Dorothy A Thompson, PhD, Consultant Clinical Scientist Visual Electrophysiology, Great Ormond Street Hospital for Children London UK; Study Director: Paul Constable, PhD, Head Of Teaching Optometry, Flinders Vision Autism Centre, Flinders University, Australia; Principal Investigator: James McPartland, PhD, Associate Professor of Child Psychiatry and Psychology, Director, Yale Developmental Disabilities Clinic, Yale University, USA

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2018
• Primary Completion (ACTUAL): March 3, 2020
• Study Completion (ACTUAL): April 3, 2020

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: electroretinogram
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 17PP33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No