100 Participants Needed

Eye Tracking for Autism Detection

(RCFET Trial)

RM
AR
Overseen ByAngela R Paxton, BS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Eye Tracking for autism detection?

Eye tracking can effectively distinguish children with autism from typically developing children by analyzing their eye movements and fixation times, achieving a classification accuracy of 85.1%. Additionally, eye tracking has been shown to detect high-functioning autism in adults with around 74% accuracy, indicating its potential as a useful tool for autism detection.12345

Is eye tracking safe for use in humans?

Eye tracking is considered safe for humans as it is non-invasive, meaning it doesn't require surgery or entering the body, and it doesn't involve any harmful procedures.23467

How does eye tracking differ from other treatments for autism?

Eye tracking for autism detection is unique because it uses technology to monitor eye movements and visual processing differences, which can help identify autism without the need for traditional behavioral assessments. This method is non-invasive and can provide early detection, especially in children, by analyzing how they focus on different visual stimuli.12358

Research Team

RR

Rebecca R McNally Keehn, PhD, HSPP

Principal Investigator

IU School of Medicine

Eligibility Criteria

This trial is for young children aged 12-48 months who are patients at Riley Hospital for Children in Indiana. They must have caregivers who speak English or Spanish and can give consent. It's not open to kids younger than 12 months, older than 48 months, or those with non-English/Spanish-speaking caregivers.

Inclusion Criteria

My child is between 1 and 4 years old and has an appointment at Riley Hospital.
My child's caregiver speaks English or Spanish.
Children must have a legal guardian that is able to provide consent

Exclusion Criteria

My child is not between 1 and 4 years old.
My caregiver does not speak English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Developmental Evaluation

Children undergo a standard of care developmental evaluation including a clinical interview and observational measures

1 day
1 visit (in-person)

Eye-Tracking Activity

Participants engage in a one-time eye-tracking activity to view pictures and movies while eye movements are tracked

15 minutes
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the eye-tracking activity

4 weeks

Treatment Details

Interventions

  • Eye Tracking
Trial OverviewThe study is testing a non-invasive eye-tracking system called Eyelink Portable Duo to see if it can help identify the risk of autism in young children during routine health care visits.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Children Undergoing Developmental EvaluationExperimental Treatment1 Intervention
Children undergoing a standard of care developmental evaluation will be enrolled into the study. After the completion of the developmental evaluation, research participation includes a one-time eye-tracking activity in which the child will view a series of different pictures and movies while their eye movements are tracked and recorded.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Findings from Research

In a study involving 74 children (37 with autism spectrum disorder and 37 typically developing), eye tracking revealed that children with ASD had significantly shorter fixation times on key areas of interest while watching a 10-second video.
The analysis showed that fixation times on the mouth and body could accurately distinguish between ASD and typically developing children with an accuracy of 85.1%, indicating that this method could be a promising tool for early detection of autism.
Applying Eye Tracking to Identify Autism Spectrum Disorder in Children.Wan, G., Kong, X., Sun, B., et al.[2021]
A multisite study involving 280 children with autism spectrum disorder (ASD) and 119 typically developing children demonstrated that eye tracking (ET) tasks effectively measure attention to human faces, with the Oculomotor Index of Gaze to Human Faces (OMI) showing strong associations with cognitive and communicative skills in ASD.
The OMI has been accepted into the FDA's Biomarker Qualification program, indicating its potential as a reliable biomarker for clinical trials in ASD, although further research is needed to assess its effectiveness in real-world settings.
The autism biomarkers consortium for clinical trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials.Shic, F., Naples, AJ., Barney, EC., et al.[2023]
The study found that children with autism spectrum disorder (ASD) had significantly smaller baseline pupil sizes compared to both mental age-matched and chronological age-matched controls, suggesting a potential biomarker for ASD.
Using eye-tracking technology, pupil responses during visual scanning could accurately predict group membership in 72% of participants, with 89% accuracy for the ASD group, indicating that pupil size may reflect underlying neurological differences associated with autism.
Can pupil size and pupil responses during visual scanning contribute to the diagnosis of autism spectrum disorder in children?Martineau, J., Hernandez, N., Hiebel, L., et al.[2011]

References

Applying Eye Tracking to Identify Autism Spectrum Disorder in Children. [2021]
The autism biomarkers consortium for clinical trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials. [2023]
Can pupil size and pupil responses during visual scanning contribute to the diagnosis of autism spectrum disorder in children? [2011]
Eye tracking in early autism research. [2021]
Detecting High-Functioning Autism in Adults Using Eye Tracking and Machine Learning. [2021]
Eye tracking young children with autism. [2021]
Eye-Tracking in Infants and Young Children at Risk for Autism Spectrum Disorder: A Systematic Review of Visual Stimuli in Experimental Paradigms. [2021]
In the eye of the beholder: a survey of models for eyes and gaze. [2010]