Autism Spectrum DisorderERG in ASDNCT03422016
Electroretinogram in Autistic Spectrum Disorders
An observational study of Autism Spectrum Disorder, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 4 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 4 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- electroretinogram (ERG)
- How many people
- 177 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 3 Sep 2018to 3 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: individuals diagnosed with ASD and typically developing controls
Who may be able to join
- cohort 1: individuals with diagnosis ASD with an IQ measure exceeding 85
- cohort 2: typically developed controls without diagnosis of ASD
Who cannot join
- a history of eye disease or treatment or seizure medicines that may alter retinal function
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Australia2 sites
Flinders University
Adelaide, South Australia
Swinburne University of Technology
Melbourne
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Trust
London, WC1N 3JH
About this study
Official title: 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).
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- electroretinogram (ERG)
- Keywords
- electroretinogram
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroretinogram (ERG)Diagnostic test
an ERG is a measure of the eyes response to a flash of light
| Study group | Role | What they receive |
|---|---|---|
| autistic spectrum disorder | intelligence quotient IQ>85 age 4-25yrs Receives: Diagnostic Test: electroretinogram (ERG) | |
| control | age 4-25yrs no eye disorder Receives: Diagnostic Test: electroretinogram (ERG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
light adapted electroretinogram
incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start3 Sep 2018
- Primary completion3 Mar 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Flinders University, Yale University, Swinburne University of Technology
- Responsible party
- Sponsor
- Investigators
- Dorothy A Thompson, PhD, Principal investigator, Consultant Clinical Scientist Visual Electrophysiology, Great Ormond Street Hospital for Children London UKPaul Constable, PhD, Study director, Head Of Teaching Optometry, Flinders Vision Autism Centre, Flinders University, AustraliaJames McPartland, PhD, Principal investigator, Associate Professor of Child Psychiatry and Psychology, Director, Yale Developmental Disabilities Clinic, Yale University, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422016
- Sponsor's protocol ID
- 17PP33
- Acronym
- ERG in ASD
- Status last verified
- Jan 2022
- First submitted
- 30 Jan 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Altered Light Responses in Children With Autistic Spectrum Disorders
- ClinicalTrials.gov ID
- NCT03422016
- Acronym / sponsor ID
- ERG in ASD / 17PP33
- Conditions
- Autism Spectrum Disorder
- Keywords
- electroretinogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Flinders University, Yale University, Swinburne University of Technology
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autistic spectrum disorder | – | Diagnostic Test: electroretinogram (ERG)intelligence quotient IQ>85 age 4-25yrs |
| control | – | Diagnostic Test: electroretinogram (ERG)age 4-25yrs no eye disorder |
Who may qualify
- Ages
- 4 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- individuals diagnosed with ASD and typically developing controls
Key inclusion criteria (2 listed)
- cohort 1: individuals with diagnosis ASD with an IQ measure exceeding 85
- cohort 2: typically developed controls without diagnosis of ASD
Key exclusion criteria (1 listed)
- a history of eye disease or treatment or seizure medicines that may alter retinal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroretinogram (ERG)an ERG is a measure of the eyes response to a flash of light | Diagnostic test | autistic spectrum disorder, control |
Primary outcome
light adapted electroretinogram
Time frame: 12 months
incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothy A Thompson, PhD principal investigator
Consultant Clinical Scientist Visual Electrophysiology, Great Ormond Street Hospital for Children London UK
Paul Constable, PhD study director
Head Of Teaching Optometry, Flinders Vision Autism Centre, Flinders University, Australia
James McPartland, PhD principal investigator
Associate Professor of Child Psychiatry and Psychology, Director, Yale Developmental Disabilities Clinic, Yale University, USA
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
light adapted electroretinogram (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.