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Completed

NCT Number: NCT04381767

EYE-SYNC Concussion Classification Study

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.

Completed

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Key information

Conditions

Concussion, Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Concussion, Brain Concussion, Cerebral Concussion, Severe Concussion; Eye Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sync-Think, Inc.

Palo Alto, California, 94306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women actively engaged in competitive athletics
  • Eye tracking measurements and SCAT5 evaluations are collected within 3-day window
  • Eye tracking measurements and SCAT5 evaluations are collected within 3 days of injury

Exclusion criteria

  • Prior enrollment (subjects may only enroll once)
  • POOR eye tracking data quality
  • Subjects without reported injury detailing alteration of consciousness (AOC) or altered mental status (AMS) defined as self-report, witness report or the following responses to the SCAT5 SSS: "Difficulty Remembering" ≥ 4 or "Confusion" ≥ 4, or scored less than 23 on the SCAT5 Standardized Assessment of Concussion (SAC) or greater than 25 on the SCAT5 Symptom Severity Score (SSS)
  • EYE-SYNC smooth pursuit standard deviation of tangential error (SDTE) variance scores < 2.0

Treatment and study plan

EYE-SYNC

Device

Evaluation of oculomotor performance using visual presentation and eye tracking analysis

Other names: SCAT-5

Primary outcomes

  1. A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics

    Time frame: 3 days

    A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard.

Sponsors and collaborators

Lead sponsor

Sync-Think, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 11, 2020
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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