Head InjuryNCT05326555
Dynamic Vision Testing and Concussion Management Dream Team 65
An observational study of Head Injury and Sport Injury, run by California State University, Northridge at 1 site in United States.
Trial summary
The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Head Injury, Sport Injury, Concussion, Brain
- What is being tested?
- Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Oct 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Due to COVID-19 and the uncertainty of which teams will be competing during the academic year, our subject pool will potentially come from any athlete who provides consent from an equal number of men's and women's teams who are competing that semester.
Who may be able to join
- • California State University Northridge athletes
- Participants are able to give consent to participate in the study
- Completion of preseason testing for the 6-condition, BESS, DVA, GST with the research team
- Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.
- Sampling of convenience on a volunteer basis
Who cannot join
- • Athletes with preseason baseline tests on BESS or DVA that are not within the normative value range for an unimpaired individual.
- The initial 6- condition BESS score is >20 errors
- The subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the DVA test.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California State University, Jacranda Hall 1578, 1576, 1574
Northridge, California, 91330-8411
Aimie Kachingwe, Dr, 818-677-4684, aimie.kachingwe@csun.edu
About this study
The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.
Read the detailed description
The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently a component of CSUN's established concussion protocol, will be administered to assess balance impairments. This cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. The results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that CSUN Athletics clears the athlete to "Return to Play."
- Conditions
- Head Injury, Sport Injury, Concussion, Brain
- Being tested
- Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System
- Medical subject headings
- Craniocerebral Trauma, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring SystemDiagnostic test
Assessment tool and computerized tests designed to evaluate postural stability and vestibulo-ocular reflex (VOR) function while assisting with return to play decision after a sports-related concussion.
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Condition BESS
Number of errors and time subject was able to hold position
Measured: October 1, 2021 - October 1, 2024
Gaze Stabilization Test (GST)
Maximum head velocity in degrees/second
Measured: October 1, 2021 - October 1, 2024
Dynamic Visual Acuity (DVA)
Log of minimal angle resolvable units (LogMAR). The number of lines on an eye chart that are lost with head moving (DVA) compared to the head steady condition, known as static visual acuity (SVA)
Measured: October 1, 2021 - October 1, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Oct 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California State University, Northridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimie Kachingwe, California State University, Northridge
- Investigators
- Aimie Kachingwe, Dr, Principal investigator, CSUNMargaret Roller, Dr, Principal investigator, CSUN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326555
- Sponsor's protocol ID
- IRB-FY22-022
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Vision Testing and Concussion Management Dream Team 65
- ClinicalTrials.gov ID
- NCT05326555
- Acronym / sponsor ID
- IRB-FY22-022
- Conditions
- Head Injury, Sport Injury, Concussion, Brain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- California State University, NorthridgeUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 13 Apr 2022 (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 determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.
Detailed description
The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently a component of CSUN's established concussion protocol, will be administered to assess balance impairments. This cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. The results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that CSUN Athletics clears the athlete to "Return to Play."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Due to COVID-19 and the uncertainty of which teams will be competing during the academic year, our subject pool will potentially come from any athlete who provides consent from an equal number of men's and women's teams who are competing that semester.
Key inclusion criteria (5 listed)
- • California State University Northridge athletes
Key exclusion criteria (3 listed)
- • Athletes with preseason baseline tests on BESS or DVA that are not within the normative value range for an unimpaired individual.
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 |
|---|---|---|
| Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring SystemAssessment tool and computerized tests designed to evaluate postural stability and vestibulo-ocular reflex (VOR) function while assisting with return to play decision after a sports-related concussion. | Diagnostic test | – |
Primary outcome
6-Condition BESS
Time frame: October 1, 2021 - October 1, 2024
Number of errors and time subject was able to hold position
Gaze Stabilization Test (GST)
Time frame: October 1, 2021 - October 1, 2024
Maximum head velocity in degrees/second
Dynamic Visual Acuity (DVA)
Time frame: October 1, 2021 - October 1, 2024
Log of minimal angle resolvable units (LogMAR). The number of lines on an eye chart that are lost with head moving (DVA) compared to the head steady condition, known as static visual acuity (SVA)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Aimie Kachingwe, Dr principal investigator
CSUN
Margaret Roller, Dr principal investigator
CSUN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury and Sport Injury, run by California State University, Northridge 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aimie Kachingwe, Dr (818-677-4684, aimie.kachingwe@csun.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Condition BESS (time frame: October 1, 2021 - October 1, 2024). The study lists 3 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 13 Apr 2022.