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NCT02573428 · ClinicalTrials.gov registry record
Evaluating the Validity of an Eye Gaze Paradigm in Predicting Autism Spectrum Disorder
A clinical trial, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 389
- Enrollment target
NCT02573428: Completed study, sponsored by The Cleveland Clinic.
NCT02573428 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 389 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02573428 has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 389 participants
- Enrollment target
Study 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 (highly subjective), clinical observations (subjective and expensive), and cognitive measurements (expensive and unavailable in many settings. This st
Primary Outcome
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 t
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-12 |
What the finished NCT02573428 record still lists
NCT02573428 is an observational study that tracks outcomes without assigning an intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02573428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02573428 about?
NCT02573428 is a clinical study titled "Evaluating the Validity of an Eye Gaze Paradigm in Predicting Autism Spectrum Disorder". 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-se...
What is the current status of trial NCT02573428?
This trial is currently completed. The enrollment target is 389 participants. The study started on 2015-06. Estimated completion is 2016-12.
Who is sponsoring clinical trial NCT02573428?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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