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Trial record 43 of 1550 for:    child psychiatry

Electroretinogram in Autistic Spectrum Disorders (ERG in ASD)

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ClinicalTrials.gov Identifier: NCT03422016
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2018
Last Update Posted : September 5, 2019
Sponsor:
Collaborators:
Flinders University
Yale University
Swinburne University of Technology
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief 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).

Condition or disease Intervention/treatment
Autism Spectrum Disorder 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.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Incidence of Altered Light Responses in Children With Autistic Spectrum Disorders
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. light adapted electroretinogram [ Time Frame: 12 months ]
    incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
individuals diagnosed with ASD and typically developing controls
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422016


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

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03422016     History of Changes
Other Study ID Numbers: 17PP33
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
electroretinogram
Additional relevant MeSH terms:
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Disease
Autism Spectrum Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders