Clinical Trial: Evaluating the Validity of an Eye Gaze Paradigm in Predicting Autism Spectrum Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Evaluating the Validity of an Eye Gaze Tracking Assessment Tool in Identifying Autism Spectrum Disorder

Brief Summary:

The primary purpose of the present study is to evaluate the diagnostic validity of eye tracking measurements acquired during viewing of socially-relevant stimuli in predicting ASD diagnosis. The secondary purpose was to explore the potential prognostic value of eye tracking measures through cross-sectional associations with non-verbal cognitive ability.

Deficits in eye gaze are a hallmark sign of autism. A large and growing body of research supports the ability of eye-tracking based measurements to sensitively discriminate individuals with ASD and healthy participants. These investigations have identified that the core deficit in autism as disruption of social attention, reflecting an inability to appropriately engage and track socially- and emotionally-relevant aspects of the visual world. Thus, eye gaze tracking, acquired during viewing of socially-relevant stimuli, may be a useful approach to identifying objective markers of ASD. Eye tracking also carries the advantages of being less intrusive and expensive than MRI and genetic testing and specifically focuses on the core neurobehavioral characteristics of ASD - abnormalities in social attention.

After diagnosis of ASD, key clinical tasks in young children involve determining an accurate prognosis and tracking the progress of early interventions. Currently, the only prognostic indicators are clinical observations (subjective and expensive) and non-verbal cognitive ability testing (difficult to acquire, time-consuming, unavailable in many settings). Recently, eye gaze tracking was found to predict functional outcomes. Thus, in addition to being an objective marker for ASD, eye tracking measurements have potential to be useful for predicting cognitive and functional outcomes. Similarly, the only available methods for tracking treatment progress are parental reports (highl

Detailed Summary:

The current study will occur in four phases: pilot testing, development, validation, and re-test. In each phase, participants will view a visual attention stimulus with social elements (social attention paradigm) while eye tracking measurements are remotely acquired. The visual attention paradigm will be refined in the pilot testing but will remain the same for development, validation, and re-test phases. The entire process, including calibration and viewing of the visual paradigm, will take about 15 minutes. The text below describes each phase in detail and the reviews specific methodology for the social attention paradigm and eye tracking procedures.

1. Pilot Phase. Pilot testing of the social attention paradigm used to elicit eye gaze measurements to ensure they are sufficiently engaging across the ages of children participating. The visual attention paradigm during this phase is expected to be 10-12 minutes. This phase will also be used to determine optimal strategies for maintaining attention throughout the testing period. Initial data may also provide some insights into the most discriminating stimulus elements to include in future phases. Investigators anticipate recruiting approximately 10 ASD and 10 non-ASD participants in this phase. The pilot phase is expected to require 2.5 months of recruitment and 0.5 months of data reduction and analysis.
2. Development Phase. Once pilot testing is completed, 30 ASD-affected and 30 non-ASD children ages 1.5 to 18 will be recruited. Each child will complete the social attention paradigm while their eye gaze is remotely tracked. Eye gaze data is then scored for more than 100 parameters and these scores are entered into a database that includes diagnostic and cognitive information about each participant. The eye tracking data is then analyzed to create the diagnostic
   Sponsor: The Cleveland Clinic
   

   Current Primary Outcome: Percentage of correctly discriminated ASD and non-ASD cases using the autism risk index. [ Time Frame: 1 year from study start ]

   In the development phase, all of the eye gaze measurements acquired from the social attention paradigm will be included as predictor variables in a random forest analysis. This analysis permits evaluation of the discriminative ability of a large number of variables in data sets with a modest number of cases. The variables with highest importance scores, indicating good diagnostic discrimination, will be entered into a logistic regression analysis with ASD diagnostic status (ASD vs. non-ASD) as the dichotomous dependent variable. Significant predictors will be retained and coefficients from the retained predictors will serve as the diagnostic autism risk index.
   
   
   

   Original Primary Outcome: Same as current
   
   

   Current Secondary Outcome:

   • Area under the ROC curve of the prognostic algorithm in discriminating non-verbal cognitive disability. [ Time Frame: 21 months from study start ]
     All the available eye tracking measurements as predictors and non-verbal cognitive ability scores (dichotomized at <70 and 70 and above) as the dependent variable in random forest analyses.
   • Number of regions of interest with significant dwell time differences between ASD-affected and non-ASD participants. [ Time Frame: 3 months from study start ]
     Effect size between ASD and non-ASD participants for dwell time relative to social targets presented in the social attention paradigm.
   • Natural Interaction, Monologue with Directed Attention Stimulus - Dwell time in Upper Face Region of Interest (ROI) from 0.5-24 seconds [ Time Frame: 6 months from study start ]
   • Natural Interaction, Monologue with Directed Attention Stimulus - Dwell time in Desk picture and Cup/Phone Regions of Interest (ROI) from 0.5-24 seconds [ Time Frame: 6 months from study start ]
   • Natural Interaction, Joke 1 Stimulus - Dwell time in the Upper and Lower Face ROIs from 0.5-5.5 seconds [ Time Frame: 6 months from study start ]
   • Natural Interaction, Joke 1 Stimulus - Dwell time in Body and Toys ROIs from 0.5-6.88 seconds [ Time Frame: 6 months from study start ]
   • Natural Interaction, Joke 2 Stimulus - Dwell time in Upper Face ROI and Lower Face ROI from 0.5-8.0 seconds [ Time Frame: 6 months from study start ]
   • Natural Interaction, Joke 2 Stimulus - Dwell time in Upper Face ROI from 4.3-5.0 seconds [ Time Frame: 6 months from study start ]
   • Natural Interaction, Joke 2 Stimulus - Dwell time in Distractor 1, Distractor 2, Distractor 3 and Body ROIs from 0.2-10.34 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gaze Middle Stimulus - Dwell time in Face ROI from 0.3-1.1 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gaze Middle Stimulus - Dwell time in Target Toy, Distractor Right and Distractor Left ROIs from 1.0-2.3 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gaze Right Stimulus - Dwell time in Face A and Face B ROIs from 3.3-3.7 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gaze Right Stimulus - Dwell time in Target Toy and Distractor Toy ROIs from 1.0-2.3 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gaze Right 2 Stimulus - Dwell time in Face ROI from 2.0-3.0 [ Time Frame: 6 months from study start ]
   • Joint Attention, Gaze Right 2 Stimulus - Dwell time in Left Distractor, Middle Distractor and Right Target from 0.9-1.6 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gesture Middle 1 Stimulus - Left Distractor, Right Distractor and Middle Target from 1.5-3.5 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gesture Right 1 Stimulus - Target Toy, Distractor Middle and Distractor Left ROIs from 0.8-3.5 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gesture Right 2 Stimulus - Target Toy and Distractor Toy ROIs from 1.3-2.4 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gesture Left 1 Stimulus - Target Toy, Distractor Middle and Distractor Right ROIs from 1.4-3.4 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention, Gesture Left 2 Stimulus - Target Toy and Distractor Right ROIs from 1.2-2.7 seconds [ Time Frame: 6 months from study start ]
   • Joint Attention - Gesture Left 3 Stimulus - Left Target, Middle Distractor and Right Distractor ROIs from 0.7-2.3 seconds [ Time Frame: 6 months from study start ]
   
   
   

   Original Secondary Outcome:

   • Area under the ROC curve of the prognostic algorithm in discriminating non-verbal cognitive disability. [ Time Frame: 21 months from study start ]
     All the available eye tracking measurements as predictors and non-verbal cognitive ability scores (dichotomized at <70 and 70 and above) as the dependent variable in random forest analyses.
   • Number of regions of interest with significant dwell time differences between ASD-affected and non-ASD participants. [ Time Frame: 3 months from study start ]
     Effect size between ASD and non-ASD participants for dwell time relative to social targets presented in the social attention paradigm.
   
   
   Information By: The Cleveland Clinic
   

   Dates:
   Date Received: October 7, 2015
   Date Started: June 2015
   Date Completion:
   Last Updated: March 10, 2017
   Last Verified: March 2017