CClinicalTrials.gg
Status unknownNCT04504890Updated Oct 23, 2020

Ocular-vestibular Biomarker Identification for ADHD

An observational study in ADHD - Combined Type, ADHD and ADHD Predominantly Inattentive Type, sponsored by Sync-Think, Inc.. Status unknown at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2020-10-23.

Sponsored by Sync-Think, Inc. · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
6 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

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

Keywords

  • ADHD
  • EYE-SYNC
  • eye tracking
  • oculomotor
  • vestibular
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In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's planned enrollment of 240 is above the median of 127 across 267 observational studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Sync-Think, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children and adults seeking diagnosis and/or treatment for attention-related disorder.

Inclusion criteria

  • Men and women ages 6-70 seeking evaluation and treatment for ADHD.

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adults - Diagnosis

    Adults seeking treatment for an attention-related disorder

    Device: EYE-SYNC

  • Adults - Prescribed

    Adults who have been diagnosed with ADHD and prescribed medication treatment for the disorder

    Device: EYE-SYNC

  • Children - Diagnosis

    Children seeking treatment for an attention-related disorder

    Device: EYE-SYNC

  • Children - Prescribed

    Children who have been diagnosed with ADHD and prescribed medication treatment for the disorder

    Device: EYE-SYNC

Interventions

  • DeviceEYE-SYNC

    Nystagmograph used to measure eye movement

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What researchers measure

Primary outcomes

  1. Eye Tracking and ADHD measure correlation

    Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables

    Time frame: through study completion, an average of 1 year

  2. 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

    Time frame: through study completion, an average of 1 year

  3. 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)

    Time frame: through study completion, an average of 1 year

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Study locations

1 of 1 sites recruiting
  • Palo Alto Medical Foundation - San Carlos Center
    San Carlos, California 94070, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04504890
Lead sponsor
Sync-Think, Inc.
Collaborators
Sutter Health
Responsible party
Sponsor
First posted
Aug 7, 2020
Start date
Jul 16, 2020
Primary completion
Aug 5, 2021 (estimated)
Completion
Oct 5, 2021 (estimated)
Last update
Oct 23, 2020

Study contacts

Benjamin Cheyette, M.D.,Ph.D.
Contact
cheyetbr@sutterhealth.org
650.278.1814

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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