Ocular-vestibular Biomarker Identification for ADHD

October 22, 2020 updated by: Sync-Think, Inc.
This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Carlos, California, United States, 94070
        • Recruiting
        • Palo Alto Medical Foundation - San Carlos Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Cheyette, M.D., Ph.D.
        • Sub-Investigator:
          • Sarah Cheyette, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eye Tracking and ADHD measure correlation
Time Frame: through study completion, an average of 1 year
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
Time Frame: 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
through study completion, an average of 1 year
MANCOVA Eye Tracking in ADHD Treatment Population
Time Frame: 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)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sync-Think, Inc.

Collaborators

Sutter Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2020

Primary Completion (Anticipated)

August 5, 2021

Study Completion (Anticipated)

October 5, 2021

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYESYNCOBIADHD2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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