EYE-SYNC Concussion Classification Study

NCT ID: NCT04381767

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-19

Study Completion Date

2020-06-23

Brief Summary

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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.

Detailed Description

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Conditions

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Concussion, Mild Concussion; Eye Concussion, Brain Concussion, Severe Brain Injuries Concussion, Cerebral

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Concussion Evaluation

Adult athletes receiving a clinical evaluation for a suspected concussion after head injury

EYE-SYNC

Intervention Type DEVICE

Evaluation of oculomotor performance using visual presentation and eye tracking analysis

Interventions

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EYE-SYNC

Evaluation of oculomotor performance using visual presentation and eye tracking analysis

Intervention Type DEVICE

Other Intervention Names

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SCAT-5

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sync-Think, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sync-Think, Inc.

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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EYESYNCCCV2020

Identifier Type: -

Identifier Source: org_study_id

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