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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

Tracking Information
First Submitted Date January 30, 2018
First Posted Date February 5, 2018
Last Update Posted Date September 5, 2019
Actual Study Start Date September 3, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2018)
light adapted electroretinogram [ Time Frame: 12 months ]
incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03422016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electroretinogram in Autistic Spectrum Disorders
Official Title The Incidence of Altered Light Responses in Children With Autistic Spectrum Disorders
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).
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population individuals diagnosed with ASD and typically developing controls
Condition Autism Spectrum Disorder
Intervention Diagnostic Test: electroretinogram (ERG)
an ERG is a measure of the eyes response to a flash of light
Study Groups/Cohorts
  • autistic spectrum disorder
    intelligence quotient IQ>85 age 4-25yrs
    Intervention: Diagnostic Test: electroretinogram (ERG)
  • control
    age 4-25yrs no eye disorder
    Intervention: Diagnostic Test: electroretinogram (ERG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: February 2, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03422016
Other Study ID Numbers 17PP33
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Great Ormond Street Hospital for Children NHS Foundation Trust
Study Sponsor Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
  • Flinders University
  • Yale 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
PRS Account Great Ormond Street Hospital for Children NHS Foundation Trust
Verification Date September 2019