Ocular-vestibular Biomarker Identification for ADHD

• Conditions: ADHD - Combined Type; ADHD, Predominantly Hyperactive - Impulsive; ADHD; ADHD Predominantly Inattentive Type
• Interventions: Device: EYE-SYNC

• Registration Number: NCT04504890
• Lead Sponsor: Sync-Think, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-07-16
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-08-05
• Study Completion: 2021-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults - Prescribed	EYE-SYNC	Adults who have been diagnosed with ADHD and prescribed medication treatment for the disorder
Adults - Diagnosis	EYE-SYNC	Adults seeking treatment for an attention-related disorder
Children - Diagnosis	EYE-SYNC	Children seeking treatment for an attention-related disorder
Children - Prescribed	EYE-SYNC	Children who have been diagnosed with ADHD and prescribed medication treatment for the disorder

Primary Outcome Measures

Name	Time	Method
Eye Tracking ADHD Diagnostic ROC	through study completion, an average of 1 year	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
Eye Tracking and ADHD measure correlation	through study completion, an average of 1 year	Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables
MANCOVA Eye Tracking in ADHD Treatment Population	through study completion, an average of 1 year	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)

Trial Locations

Locations (1)

Palo Alto Medical Foundation - San Carlos Center; 🇺🇸 San Carlos, California, United States