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Oculogica Portable EyeBOX Study

NCT05047003 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-09-07

No results posted yet for this study

Summary

The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion. The utility of the portable assessment to aid in the monitoring of symptoms over time after an initial diagnosis of concussion will also be evaluated.

Conditions

  • Concussion, Brain
  • Mild Traumatic Brain Injury

Interventions

DIAGNOSTIC_TEST

EyeBOX Model EBX-4 (Portable version)

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.

Sponsors & Collaborators

  • Oculogica, Inc.

    lead INDUSTRY

Principal Investigators

  • Rosina Samadani, PhD · Oculogica, Inc.

  • Amy Romandine-Kratz, MD · Prevea Health

  • Mario Chavez, DC · Redlands Chiropractic

  • Brian Lease, PT · Westfields Hospital

  • Yang K Lo, MD · CentraCare

Eligibility

Min Age
5 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-19
Primary Completion
2022-09-01
Completion
2022-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05047003 on ClinicalTrials.gov