- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04381767
EYE-SYNC Concussion Classification Study
June 23, 2020 updated by: Sync-Think, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1303
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94306
- Sync-Think, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Concussion Evaluation
Adult athletes receiving a clinical evaluation for a suspected concussion after head injury
|
Evaluation of oculomotor performance using visual presentation and eye tracking analysis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2018
Primary Completion (Actual)
March 23, 2020
Study Completion (Actual)
June 23, 2020
Study Registration Dates
First Submitted
May 6, 2020
First Submitted That Met QC Criteria
May 6, 2020
First Posted (Actual)
May 11, 2020
Study Record Updates
Last Update Posted (Actual)
June 25, 2020
Last Update Submitted That Met QC Criteria
June 23, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EYESYNCCCV2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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