EYE-SYNC Concussion Classification Study

NCT04381767 | Completed FDA Device

• 1 other identifier: EYESYNCCCV2020
• Study Type: observational
• Target: 1,303
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  3 days

Study Arms (1)

Concussion Evaluation

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

Device: EYE-SYNC

Interventions

EYE-SYNC DEVICE

Evaluation of oculomotor performance using visual presentation and eye tracking analysis

Also known as: SCAT-5

Concussion Evaluation

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will include all patients evaluated for potential traumatic brain injury presenting to the sports medicine clinicians in an athletic environment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sync-Think, Inc.: lead

Study Sites (1)

Sync-Think, Inc.

Palo Alto, California, 94306, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: December 19, 2018
• Primary Completion: March 23, 2020
• Study Completion: June 23, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)