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EyeBOX Concussion Study and Registry

NCT03966404 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-09-07

No results posted yet for this study

Summary

The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.

Conditions

  • Concussion, Brain
  • Mild Traumatic Brain Injury

Interventions

DIAGNOSTIC_TEST

EyeBOX device

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.

Sponsors & Collaborators

  • Oculogica, Inc.

    lead INDUSTRY

Principal Investigators

  • Rosina Samadani, PhD · Oculogica, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2023-06-01
Completion
2023-06-01
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 NCT03966404 on ClinicalTrials.gov