Electroretinogram in Autistic Spectrum Disorders

NCT ID: NCT03422016

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

177 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-03

Study Completion Date

2020-04-03

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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autistic spectrum disorder

intelligence quotient IQ\>85 age 4-25yrs

electroretinogram (ERG)

Intervention Type DIAGNOSTIC_TEST

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

control

age 4-25yrs no eye disorder

electroretinogram (ERG)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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electroretinogram (ERG)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Flinders University

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Swinburne University of Technology

OTHER

Sponsor Role collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dorothy A Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

Consultant Clinical Scientist Visual Electrophysiology, Great Ormond Street Hospital for Children London UK

Paul Constable, PhD

Role: STUDY_DIRECTOR

Head Of Teaching Optometry, Flinders Vision Autism Centre, Flinders University, Australia

James McPartland, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Child Psychiatry and Psychology, Director, Yale Developmental Disabilities Clinic, Yale University, USA

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Flinders University

Adelaide, South Australia, Australia

Site Status

Swinburne University of Technology

Melbourne, , Australia

Site Status

Great Ormond Street Hospital for Children NHS Trust

London, , United Kingdom

Site Status

Countries

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United States Australia United Kingdom

Other Identifiers

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17PP33

Identifier Type: -

Identifier Source: org_study_id

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