Electroretinogram in Autistic Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

— ERG in ASD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422016
• Other study ID #: 17PP33
• Status: Completed
• Start date: September 3, 2018
• Est. completion date: April 3, 2020

Study information

• Verified date: January 2022
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: April 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Diagnostic Test:
• electroretinogram (ERG)
an ERG is a measure of the eyes response to a flash of light

Locations

Country	Name	City	State
Australia	Flinders University	Adelaide	South Australia
Australia	Swinburne University of Technology	Melbourne
United Kingdom	Great Ormond Street Hospital for Children NHS Trust	London
United States	Yale University	New Haven	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust	Flinders University, Swinburne University of Technology, Yale University

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	light adapted electroretinogram	incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder	12 months