Assessing Eye Tracking Features Following Sports-Related Concussion

Traumatic Brain Injury Clinical Trial

Official title:

Assessing Eye Tracking Features Following Sports-Related Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103803
• Other study ID #: 13-009632
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: November 11, 2015
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This proposal aims to describe the oculometric features present during King-Devick (K-D) testing for subjects who experienced sports-related concussion. The investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased K-D test time. Understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.

Description:

This proposal aims to describe the oculometric features present during K-D testing for subjects who experienced sports-related concussion. The investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased K-D test time. Understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.

The main objectives include:

1. Describing the oculometric deficits present in subjects with acute sports-related concussion.

2. Analyzing and quantifying the oculometric changes that occur during subject recovery.

3. Identifying possible oculometric features as potential biomarkers that may lead to reliable, rapid method for recognizing acute concussion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

Inclusion criteria:

• Over the age of 8 years, and able to provide informed consent / assent.

• Have documented diagnosis of sports-related concussion within two weeks of the event.

• Currently demonstrating post-concussion symptoms.

Exclusion criteria:

• Alcohol consumption within 48 hours of evaluation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Lee Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in time to complete King-Devick Test	The King-Devick Test (K-D Test) is a two-minute test that requires an athlete to read single digit numbers displayed. Subjects will be seated in front of a computer screen and eye tracking device connected to the computer. The eye tracking device consists of infrared cameras, which captured eye movements by tracking the reflections of infrared reference lights on the subjects' retinas. Before the start of the experiment, they will begin by watching a moving target on the computer screen to calibrate the system. Then, the subject completes a computerized version of the K-D test. The K-D test requires that the subject rapidly read aloud the numbers presented on the three test cards. Reading the three test cards requires less than two minutes to complete. The number of errors will be counted. Oculometric data will be collected during the test and analyzed offline. The total time required to complete all three test cards is the completion time for the entire K-D test.	Baseline to 4 weeks	No