NCT04560400

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

September 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

September 13, 2020

Last Update Submit

February 21, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    Within 10 years of last concussion

  • 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.

    Within 10 years of last concussion

Study Arms (6)

No Concussion Conventional KD

SHAM COMPARATOR

Participants without concussion history perform conventional King-Devick Test.

Diagnostic Test: Conventional King-Devick test

No Concussion Reverse KD

ACTIVE COMPARATOR

Participants without concussion history perform reverse King-Devick Test.

Diagnostic Test: Reverse King-Devick test

Single Concussion Conventional KD

SHAM COMPARATOR

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

Diagnostic Test: Conventional King-Devick test

Single Concussion Reverse KD

ACTIVE COMPARATOR

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

Diagnostic Test: Reverse King-Devick test

Multiple Concussion Conventional KD

SHAM COMPARATOR

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

Diagnostic Test: Conventional King-Devick test

Multiple Concussion Reverse KD

ACTIVE COMPARATOR

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

Diagnostic Test: Reverse King-Devick test

Interventions

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

Multiple Concussion Conventional KDNo Concussion Conventional KDSingle Concussion Conventional KD

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

Multiple Concussion Reverse KDNo Concussion Reverse KDSingle Concussion Reverse KD

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2020

First Posted

September 23, 2020

Study Start

September 20, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations