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Reverse King-Devick Test and History of Multiple Concussions

Primary Purpose

Concussion, Mild

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional King-Devick test
Reverse King-Devick test
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Concussion, Mild

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. between 18 and 26 years old,
  2. enrolled as an IU Bloomington student
  3. a fluent English speaker.

Exclusion Criteria:

  1. proficient fluency of any language that reads right to left (e.g. Arabic, Hebrew, Persian/ Farsi, Urdu Sindhi) or top to bottom and right to left (e.g. Japanese, Korean, or Chinese)
  2. a history of only one diagnosed concussion
  3. any visual, ocular, or brain injury within the past 12 months
  4. any history of an eye movement disorder
  5. any noncorrected visual impairment
  6. a diagnosis of attention deficit/hyperactivity disorder, attention deficit disorder, dyslexia, dyscalculia, or a language processing disorder.

Sites / Locations

  • Indiana University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Sham Comparator

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Active Comparator

Arm Label

No Concussion Conventional KD

No Concussion Reverse KD

Single Concussion Conventional KD

Single Concussion Reverse KD

Multiple Concussion Conventional KD

Multiple Concussion Reverse KD

Arm Description

Participants without concussion history perform conventional King-Devick Test.

Participants without concussion history perform reverse King-Devick Test.

Participants with 1 concussion history perform conventional King-Devick Test.

Participants with 1 concussion history perform reverse King-Devick Test.

Participants with 2 or more concussion history perform conventional King-Devick Test.

Participants with 2 or more concussion history perform reverse King-Devick Test.

Outcomes

Primary Outcome Measures

Between-group difference King-Devick test speed between conventional and reverse direction
The comparison in King-Devick test speed (in second) between conventional reading direction of King-Devick test and reverse direction of King-Devick test will be made in each group (multiple concussion history, single concussion history, and no concussion history).
ROC diagnostic accuracy of reverse King-Devick test to differentiate concussion history
ROC test will be performed to test the diagnostic accuracy of King-Devick test speed (in second), with reverse reading direction having superior diagnostic accuracy to identify individuals with multiple concussion history compared to the use of conventional reading direction of the King-Devick test.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2020
Last Updated
February 21, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04560400
Brief Title
Reverse King-Devick Test and History of Multiple Concussions
Official Title
Effects of Reading Direction and History of Multiple Concussions on King-Devick Test
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the effects of concussion history and reading direction on baseline King- Devick Test (KDT) performance, a common component of sideline concussion assessments. The KDT is a timed assessment of saccades, or quick movements of the eyes between two points. This test is a form of rapid automatized naming and involved subjects reading digits arranged on a tablet screen as quickly and accurately as possible. The test has three progressively more challenging test "cards," as the horizontal guidelines between digits disappear from test card 1 to 2, and the vertical spacing between the lines of digits decreases from test card 2 to 3. KDT performance is evaluated in terms of both speed (duration to all three test cards) and the number of errors (digits read incorrectly or omitted). Previous studies have identified several factors that affect KDT performance aside from head injury, including age, sex, sleep deprivation, learning disabilities, and first languages other than English. History of concussion has not been shown to influence KDT performance. The investigators hypothesize that since the left-to-right (L-R) reading direction of the KDT is the same way in which to read English, the long-term effects of prior concussions on saccadic eye movements may be masked. The investigators want to answer the following three research questions: 1) What is the effect of KDT reading direction on baseline KDT performance? If the test is performed by reading digits in a right-to-left (R-L) direction, will KDT times be slower and the number of errors increase relative to a typical L-R KDT? 2) What is the effect of a history of multiple concussions on KDT performance relative to no history of concussion? 3) Is the R-L KDT more sensitive to a history of multiple concussions? The investigators hypothesize that individuals with a history of multiple concussions will perform significantly worse (longer test durations, more errors) than individuals with no concussion history on the R-L KDT. On the other hand, the investigators hypothesize that baseline performance on the traditional L-R KDT will not be able to discriminate individuals with a history of multiple concussions from those with no concussion history.
Detailed Description
Subjects will first be asked to complete a questionnaire. This questionnaire will collect demographic data (age, sex, years of education, native language and other languages spoken) and other pertinent data (vision correction, concussion history, ocular/visual injury and disorder history, learning disability diagnoses). The questionnaire will take approximately 3 minutes to complete. Based on the concussion history provided in the questionnaire, the subject will be assigned to either Group NoHx (no concussion history) or Group HxMC (history of multiple concussions.) Then the subject will be randomized into one of two KDT formats: L-R KDT (natural reading direction) or R-L KDT (reverse reading direction) via a coin flip. The researcher will explain the KDT procedure by saying, "This test evaluates your saccadic eye movements, or rapid eye movements from one fixation point to the next. This test is comprised of three test cards. Each test card has eight lines of several digits (numbers). Please read the digits aloud as quickly but as accurately as possible from [L-R condition: 'left to right and top to bottom'; R-L condition: 'right to left and top to bottom']. If participants make a mistake, correct it if participants can and continue on. This is a timed test--tapping the tablet screen starts and stops the stopwatch. Participants will have a brief break in between cards to catch participants' breath. Each test card will get progressively harder. The horizontal lines guiding participants from digit to digit on each line on Test Card 1 disappear on Test Card 2. The lines of digits on Test Card 3 are closer together than they were on Test Card 2. Do you have any questions?" The researcher will start the app and pull up the demonstration card for the L-R condition. For the R-L condition, the researcher will open a picture of the adapted demonstration card with the diagonal lines switched to indicate that subjects follow from the left-most digit to the right-most digit on the subsequent line. Subjects will complete the demonstration card twice according their condition instructions. Subjects will be reminded to "read the digits as quickly but accurately as possible" and in the direction according to their assigned test condition before starting the test. The researcher will silently count any errors while the subject completes each test card one at a time, taking a brief (1-2s) pause after tapping the screen to stop the timer and tapping again to start the timer and bringing up the next test card. At the conclusion of the test, the researcher will record the total time and number of errors on the subject data collection sheet. The subject will complete the test a second time, following the same instructions. The total time and number of errors for the second attempt will also be recorded. The investigators anticipate this portion of the data collection to take approximately 6 minutes. The total duration of the data collection will be approximately 10 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Concussion Conventional KD
Arm Type
Sham Comparator
Arm Description
Participants without concussion history perform conventional King-Devick Test.
Arm Title
No Concussion Reverse KD
Arm Type
Active Comparator
Arm Description
Participants without concussion history perform reverse King-Devick Test.
Arm Title
Single Concussion Conventional KD
Arm Type
Sham Comparator
Arm Description
Participants with 1 concussion history perform conventional King-Devick Test.
Arm Title
Single Concussion Reverse KD
Arm Type
Active Comparator
Arm Description
Participants with 1 concussion history perform reverse King-Devick Test.
Arm Title
Multiple Concussion Conventional KD
Arm Type
Sham Comparator
Arm Description
Participants with 2 or more concussion history perform conventional King-Devick Test.
Arm Title
Multiple Concussion Reverse KD
Arm Type
Active Comparator
Arm Description
Participants with 2 or more concussion history perform reverse King-Devick Test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Conventional King-Devick test
Intervention Description
Conventional King-Devick test involves a series of number reading task from left to right and top to bottom, intending to test subjects' neuro-ophthalmologic function
Intervention Type
Diagnostic Test
Intervention Name(s)
Reverse King-Devick test
Intervention Description
Reverse King-Devick test involves a series of number reading task from right to left and bottom to top, intending to test subjects' neuro-ophthalmologic function
Primary Outcome Measure Information:
Title
Between-group difference King-Devick test speed between conventional and reverse direction
Description
The comparison in King-Devick test speed (in second) between conventional reading direction of King-Devick test and reverse direction of King-Devick test will be made in each group (multiple concussion history, single concussion history, and no concussion history).
Time Frame
Within 10 years of last concussion
Title
ROC diagnostic accuracy of reverse King-Devick test to differentiate concussion history
Description
ROC test will be performed to test the diagnostic accuracy of King-Devick test speed (in second), with reverse reading direction having superior diagnostic accuracy to identify individuals with multiple concussion history compared to the use of conventional reading direction of the King-Devick test.
Time Frame
Within 10 years of last concussion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: between 18 and 26 years old, enrolled as an IU Bloomington student a fluent English speaker. Exclusion Criteria: proficient fluency of any language that reads right to left (e.g. Arabic, Hebrew, Persian/ Farsi, Urdu Sindhi) or top to bottom and right to left (e.g. Japanese, Korean, or Chinese) a history of only one diagnosed concussion any visual, ocular, or brain injury within the past 12 months any history of an eye movement disorder any noncorrected visual impairment a diagnosis of attention deficit/hyperactivity disorder, attention deficit disorder, dyslexia, dyscalculia, or a language processing disorder.
Facility Information:
Facility Name
Indiana University School of Public Health
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Reverse King-Devick Test and History of Multiple Concussions

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