Ocular-vestibular Biomarker Identification for ADHD

ADHD Clinical Trial

Official title:

Ocular-vestibular Biomarker Identification for ADHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04504890
• Other study ID #: EYESYNCOBIADHD2020
• Status: Recruiting
• Start date: July 16, 2020
• Est. completion date: October 5, 2021

Study information

• Verified date: October 2020
• Source: Sync-Think, Inc.
• Contact: Benjamin Cheyette, M.D.,Ph.D.
• Phone: 650.278.1814
• Email: cheyetbr[@]sutterhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 5, 2021
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• ADHD - Combined Type
• ADHD Predominantly Inattentive Type
• ADHD, Predominantly Hyperactive - Impulsive
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis
• Impulsive Behavior

Intervention

Device:
• EYE-SYNC
Nystagmograph used to measure eye movement

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation - San Carlos Center	San Carlos	California

Sponsors (2)

Lead Sponsor	Collaborator
Sync-Think, Inc.	Sutter Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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