Ocular-vestibular Biomarker Identification for ADHD

Study Overview
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Brief Summary
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This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD.

Detailed Description
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This study will use a predictive visual tracking paradigm (SyncThink EYE-SYNC eye tracking paradigm) to dynamically capture the participants' attentional state. It will examine the validity of the eye tracking paradigm in identifying the disruption in attentional networks caused by ADHD by examining the association between eye tracking performances and well-established standardized measures of ADHD.

Official Title
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Ocular-vestibular Biomarker Identification for ADHD

Conditions
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ADHD - Combined Type, ADHD, ADHD Predominantly Inattentive Type, ADHD, Predominantly Hyperactive - Impulsive

Intervention / Treatment
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* Device: EYE-SYNC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ages 6-70 seeking evaluation and treatment for ADHD. Exclusion Criteria: Clinical diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other major neurological condition. Clinical diagnosis of any of the following eye-sight abnormalities: uncorrected amblyopia, uncorrected myopia, uncorrected presbyopia, uncorrected farsightedness or uncorrected Astigmatism. Psychiatric history with any of the following: LIFETIME: Clinical diagnosis of a psychotic disorder; bipolar disorder LAST YEAR: Clinical diagnosis of major depressive disorder; PTSD; clinical diagnosis of substance abuse disorder; major anxiety disorder Use of a psychotropic medication Impairment of cranial nerves II-VI Participants who receive a 'Poor' or 'Fair' eye tracking quality result on either their baseline or follow-up evaluations will be excluded from analysis. Subjects may not repeat participation

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults - Diagnosis<br>Adults seeking treatment for an attention-related disorder | Device: EYE-SYNC<br>* Nystagmograph used to measure eye movement<br>|
| Adults - Prescribed<br>Adults who have been diagnosed with ADHD and prescribed medication treatment for the disorder | Device: EYE-SYNC<br>* Nystagmograph used to measure eye movement<br>|
| Children - Diagnosis<br>Children seeking treatment for an attention-related disorder | Device: EYE-SYNC<br>* Nystagmograph used to measure eye movement<br>|
| Children - Prescribed<br>Children who have been diagnosed with ADHD and prescribed medication treatment for the disorder | Device: EYE-SYNC<br>* Nystagmograph used to measure eye movement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye Tracking and ADHD measure correlation | Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables | through study completion, an average of 1 year | 
| Eye Tracking ADHD Diagnostic ROC | Specific eye tracking parameters will be compared to determine which have the greatest diagnostic utility. Supervised machine learning models will be generated and optimized ROC AUC for both children and adults using eye tracking parameters as input and CAARS indices, CBRS indices, and clinical diagnosis as outcomes | through study completion, an average of 1 year | 
| MANCOVA Eye Tracking in ADHD Treatment Population | Repeated measures multivariate analysis of covariance (MANCOVA) will be used to compare eye tracking performance over time in adults and children with ADHD (medicated and unmedicated) | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, EYE-SYNC, eye tracking, oculomotor, vestibular