Trials Sponsors Conditions Drugs Pricing

Conditions

Concussion, Brain Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

diagnostic accuracy of initial clinical diagnosis of concussion
sensitivity and specificity compared to initial clinical diagnosis of concussion
day 0 (when patient first presents for evaluation)
diagnostic accuracy of clinical diagnosis of post-concussion symptoms
sensitivity and specificity compared to clinical diagnosis of post-concussion symptoms
up to one year after initial presentation
adverse events
adverse events occurring during use of the diagnostic device
through study participation, up to one year

Secondary Outcomes (2)

diagnostic accuracy of initial clinical diagnosis of concussion
day 0 (when patient first presents for evaluation)
correlation with increases or decreases in post-concussion symptom severity
up to one year after initial presentation

Interventions

EyeBOX deviceDiagnostic test

The EyeBOX medical device tracks a patient's eye movement and calculates a BOX Score ranging from 0-20. The BOX score is interpreted as a binary classification for eye movement abnormalities, where anything equal to or greater than 10 is a positive result for the initial evaluation of concussion and everything below 10 is negative.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

All consecutive subjects who meet all of the inclusion criteria and none of the exclusion criteria

You may qualify if:

Provide written informed consent or assent along with guardian consent.

Sponsors & Collaborators

Oculogica, Inc.
Industrylead

Study Sites (1)

New York Sports Medicine Institute

White Plains, New York, 10604, United States

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

Rosina Samadani, PhD
Oculogica, Inc.
STUDY DIRECTOR

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 1 Year
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 29, 2019

Study Start

August 5, 2019

Actual (reported)

EyeBOX Concussion Study and Registry

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations