NCT02103803

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

March 19, 2014

Last Update Submit

November 11, 2015

Conditions

Keywords

concussionsports-related concussionmild traumatic brain injury (mTBI)eye trackingoculometrics

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Alcohol consumption within 48 hours of evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Concussion

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Gaurav Pradhan, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Jan Stepanek, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Jamie Bogle, AuD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Consultant

Study Record Dates

First Submitted

March 19, 2014

First Posted

April 4, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations