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 the initial 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 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 (3)

Diagnostic accuracy to identify increases or decreases in post-concussion symptom severity
Up to one year after initial presentation
Subgroup analyses
Up to one year after initial presentation
Diagnostic accuracy of initial clinical diagnosis of concussion
Day 0 (when patient first presents for evaluation)

Study Arms (1)

Patients under evaluation for Suspected Concussion

Device: EyeBOX Model EBX-4 (Portable version)

Diagnostic Test: EyeBOX Model EBX-4 (Portable version)

Interventions

EyeBOX Model EBX-4 (Portable version)Diagnostic test

The portable EyeBOX takes less than 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high-speed camera continuously records gaze positions. The Portable EyeBOX software detects subtle changes in eye movements consistent with concussion and calculates a BOX score.

Patients under evaluation for Suspected Concussion

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

Eligibility Criteria

Age5 Years - 67 Years

Sexall

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 documented informed consent or assent along with guardian consent.

Sponsors & Collaborators

Oculogica, Inc.
Industrylead

Study Sites (4)

Redlands Chiropractic

Redlands, California, 92373, United States

CentraCare

Saint Cloud, Minnesota, 56303, United States

Prevea Health

Green Bay, Wisconsin, 54303, United States

Westfields Hospital

New Richmond, Wisconsin, 54017, 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
Amy Romandine-Kratz, MD
Prevea Health
PRINCIPAL INVESTIGATOR
Mario Chavez, DC
Redlands Chiropractic
PRINCIPAL INVESTIGATOR
Brian Lease, PT
Westfields Hospital
PRINCIPAL INVESTIGATOR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 16, 2021

Study Start

December 19, 2020

Actual (reported)

Oculogica Portable EyeBOX Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

Patients under evaluation for Suspected Concussion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

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

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

Patients under evaluation for Suspected Concussion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations