Concussion, MildNCT04560400
Reverse King-Devick Test and History of Multiple Concussions
A study testing Conventional King-Devick test and Reverse King-Devick test in people with Concussion, Mild, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Conventional King-Devick test and Reverse King-Devick test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 18 and 26 years old,
- enrolled as an IU Bloomington student
- a fluent English speaker.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Public Health
Bloomington, Indiana, 47405
About this study
Official title: Effects of Reading Direction and History of Multiple Concussions on King-Devick Test
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.
Read the 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.
- Conditions
- Concussion, Mild
- Being tested
- Conventional King-Devick test, Reverse King-Devick test
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional King-Devick testDiagnostic test
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
Reverse King-Devick testDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| No Concussion Conventional KD | Sham comparator | Participants without concussion history perform conventional King-Devick Test. Receives: Diagnostic Test: Conventional King-Devick test |
| No Concussion Reverse KD | Active comparator | Participants without concussion history perform reverse King-Devick Test. Receives: Diagnostic Test: Reverse King-Devick test |
| Single Concussion Conventional KD | Sham comparator | Participants with 1 concussion history perform conventional King-Devick Test. Receives: Diagnostic Test: Conventional King-Devick test |
| Single Concussion Reverse KD | Active comparator | Participants with 1 concussion history perform reverse King-Devick Test. Receives: Diagnostic Test: Reverse King-Devick test |
| Multiple Concussion Conventional KD | Sham comparator | Participants with 2 or more concussion history perform conventional King-Devick Test. Receives: Diagnostic Test: Conventional King-Devick test |
| Multiple Concussion Reverse KD | Active comparator | Participants with 2 or more concussion history perform reverse King-Devick Test. Receives: Diagnostic Test: Reverse King-Devick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Within 10 years of last concussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start20 Sep 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keisuke Kawata, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560400
- Sponsor's protocol ID
- 1906713722
- Status last verified
- Feb 2023
- First submitted
- 13 Sep 2020
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reading Direction and History of Multiple Concussions on King-Devick Test
- ClinicalTrials.gov ID
- NCT04560400
- Acronym / sponsor ID
- 1906713722
- Conditions
- Concussion, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| No Concussion Conventional KD | Sham comparator | Diagnostic Test: Conventional King-Devick testParticipants without concussion history perform conventional King-Devick Test. |
| No Concussion Reverse KD | Active comparator | Diagnostic Test: Reverse King-Devick testParticipants without concussion history perform reverse King-Devick Test. |
| Single Concussion Conventional KD | Sham comparator | Diagnostic Test: Conventional King-Devick testParticipants with 1 concussion history perform conventional King-Devick Test. |
| Single Concussion Reverse KD | Active comparator | Diagnostic Test: Reverse King-Devick testParticipants with 1 concussion history perform reverse King-Devick Test. |
| Multiple Concussion Conventional KD | Sham comparator | Diagnostic Test: Conventional King-Devick testParticipants with 2 or more concussion history perform conventional King-Devick Test. |
| Multiple Concussion Reverse KD | Active comparator | Diagnostic Test: Reverse King-Devick testParticipants with 2 or more concussion history perform reverse King-Devick Test. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- between 18 and 26 years old,
- enrolled as an IU Bloomington student
- a fluent English speaker.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional King-Devick testConventional 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 | Diagnostic test | Multiple Concussion Conventional KD, No Concussion Conventional KD, Single Concussion Conventional KD |
| Reverse King-Devick testReverse 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 | Diagnostic test | Multiple Concussion Reverse KD, No Concussion Reverse KD, Single Concussion Reverse KD |
Primary outcome
Between-group difference King-Devick test speed between conventional and reverse direction
Time frame: Within 10 years of last concussion
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
Time frame: Within 10 years of last concussion
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional King-Devick test and Reverse King-Devick test in people with Concussion, Mild, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference King-Devick test speed between conventional and reverse direction (time frame: Within 10 years of last concussion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.