Assessing Eye Tracking Features Following Sports-Related Concussion

November 11, 2015 updated by: Jamie M. Bogle, Au.D., Ph.D., Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

11

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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twenty subjects with diagnosed concussion will be recruited from the adolescent and adult population seen in the Comprehensive Concussion Program at Mayo Clinic Arizona.

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in time to complete King-Devick Test
Time Frame: Baseline to 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Lee Family Foundation

Investigators

  • Principal Investigator: Gaurav Pradhan, PhD, Mayo Clinic
  • Principal Investigator: Jan Stepanek, MD, Mayo Clinic
  • Principal Investigator: Jamie Bogle, AuD, PhD, Mayo Clinic

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

February 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 11, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-009632

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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