Brain Injuries, TraumaticLAPDYANCT05942638
Longitudinal Assessment of Post-concussion Driving in Young Adults
An observational study of Brain Injuries, Traumatic and Concussion, Brain, run by University of Georgia at 1 site in United States.
Trial summary
Upwards of 3.8 million concussions occur annually in the United States. Driving is a highly complicated activity that requires visual, motor, and cognitive skills, which are commonly impaired after concussion. Yet, the time course of post-concussion driving impairment has not been characterized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic, Concussion, Brain, Brain Injury Traumatic Mild
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2023to Jun 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Athletes rostered in an organized sport at the collegiate level
Who may be able to join
- 18 years old or older
- Possesses a valid driver's license
- 1 year or more of driving experience
- Normal or corrected-to-normal vision
- Rostered on an organized athletic team at the college level
- (Concussion Group Only) Diagnosed with concussion by a physician and meet inclusion criteria above.
Who cannot join
- Four or more previous concussions
- A concussion within the past 6 months
- History of any major neurological disorders or injuries
- Current use of any medications that evoke drowsiness (prescription or over the counter)
- Current orthopedic condition that interferes with driving (e.g. a walking boot, shoulder immobilizer)
- Heavy use of alcohol (binge drinking 5+ days in the past 30 days)
- Any illegal drug use (any illegal substance use)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Upwards of 3.8 million concussions occur annually in the United States. Driving is a highly complicated activity that requires visual, motor, and cognitive skills, which are commonly impaired after concussion. Yet, the time course of post-concussion driving impairment has not been characterized. There is a critical need to 1) determine when concussed individuals should return to driving and 2) identify the key concussion assessment predictors of readiness to return to driving. In the absence of formal recommendations, impaired concussed drivers are at risk to themselves and others on the road.
The first specific aim is to compare simulated driving between concussed individuals and non-concussed yoked matched controls across five longitudinal timepoints (pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance) and daily naturalistic driving from day 2 to day 9.
Read more
Driving recommendations must be appropriate and necessitated by concussion impairments, since excessively strict recommendations wrongfully strip concussed patients of their independence and may dissuade individuals from seeking medical care. The second specific aim is to identify widely used concussion assessment outcomes that predict simulated driving performance among concussed individuals throughout concussion recovery.
To address these aims, 100 concussed and 100 yoked matched control young adult college athletes will complete a simulated driving assessment and a robust concussion assessment battery at pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance. Naturalistic driving (measured with in-car global positioning systems) will be captured from day 2 to day 9 (7 days total).
This study will determine the acute and subacute time course of post-concussion driving impairment and determine key predictors of post-concussion driving performance. Results from this innovative approach will have a broad and positive impact that will improve the safety of both concussed individuals and the general population, guide the practices of health professionals, inform the future work of researchers, and substantiate the work of policy-makers by providing evidence-based recommendations for managing post-concussion driving.
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Concussion Group | Not described | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Centerline Crossings (count)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline
Centerline Crossings (count)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Measured: Day 2
Centerline Crossings (count)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Measured: Day 4
Centerline Crossings (count)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Centerline Crossings (count)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Road edge excursions (count)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline
Road edge excursions (count)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Measured: Day 2
Road edge excursions (count)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Measured: Day 4
Road edge excursions (count)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Road edge excursions (count)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Total Collisions (count)
Count of collisions during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline
Total Collisions (count)
Count of collisions during a custom STISIM3 driving simulation scenario
Measured: Day 2
Total Collisions (count)
Count of collisions during a custom STISIM3 driving simulation scenario
Measured: Day 4
Total Collisions (count)
Count of collisions during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Total Collisions (count)
Count of collisions during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Standard Deviation of Lane Position (feet)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline
Standard Deviation of Lane Position (feet)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Measured: Day 2
Standard Deviation of Lane Position (feet)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Measured: Day 4
Standard Deviation of Lane Position (feet)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Standard Deviation of Lane Position (feet)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Standard Deviation of speed (miles per hour)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline
Standard Deviation of speed (miles per hour)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Measured: Day 2
Standard Deviation of speed (miles per hour)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Measured: Day 4
Standard Deviation of speed (miles per hour)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Standard Deviation of speed (miles per hour)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Number of drives per day (count)
Total number of drives per day captured as a naturalistic driving outcomes
Measured: Up to 9 days post-injury
Distance travelled per day (miles)
Total distance driven per day captured as a naturalistic driving outcomes
Measured: Up to 9 days post-injury
Drive time per day (minutes)
Total drive time per day captured as a naturalistic driving outcomes
Measured: Up to 9 days post-injury
Total symptom severity score
Total sum of 0-6 ratings across 22 symptom items (SCAT6)
Measured: Day 2
Total symptom severity score
Total sum of 0-6 ratings across 22 symptom items (SCAT6)
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Total symptom severity score
Total sum of 0-6 ratings across 22 symptom items (SCAT6)
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Verbal Memory
Verbal memory domain score from CNS Vital Signs
Measured: Day 2
Verbal Memory
Verbal memory domain score from CNS Vital Signs
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Verbal Memory
Verbal memory domain score from CNS Vital Signs
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Visual Memory
Visual memory domain score from CNS Vital Signs
Measured: Day 2
Visual Memory
Visual memory domain score from CNS Vital Signs
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Visual Memory
Visual memory domain score from CNS Vital Signs
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Psychomotor Speed
Psychomotor speed domain score from CNS Vital Signs
Measured: Day 2
Psychomotor Speed
Psychomotor speed domain score from CNS Vital Signs
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Psychomotor Speed
Psychomotor speed domain score from CNS Vital Signs
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Reaction Time
Reaction time domain score from CNS Vital Signs
Measured: Day 2
Reaction Time
Reaction time domain score from CNS Vital Signs
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Reaction Time
Reaction time domain score from CNS Vital Signs
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Complex attention
Complex attention domain score from CNS Vital Signs
Measured: Day 2
Complex attention
Complex attention domain score from CNS Vital Signs
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Complex attention
Complex attention domain score from CNS Vital Signs
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Cognitive Flexibility
Cognitive flexibility domain score from CNS Vital Signs
Measured: Day 2
Cognitive Flexibility
Cognitive flexibility domain score from CNS Vital Signs
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Cognitive Flexibility
Cognitive flexibility domain score from CNS Vital Signs
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Processing Speed
Processing speed domain score from CNS Vital Signs
Measured: Day 2
Processing Speed
Processing speed domain score from CNS Vital Signs
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Processing Speed
Processing speed domain score from CNS Vital Signs
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Executive function
Executive functions domain score from CNS Vital Signs
Measured: Day 2
Executive function
Executive functions domain score from CNS Vital Signs
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Executive function
Executive functions domain score from CNS Vital Signs
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Balance Error Scoring System Total Error Score (count)
Number of errors committed during the Balance Error Scoring System
Measured: Day 2
Balance Error Scoring System Total Error Score (count)
Number of errors committed during the Balance Error Scoring System
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Balance Error Scoring System Total Error Score (count)
Number of errors committed during the Balance Error Scoring System
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Tandem Gait Time (seconds)
Seconds to complete the tandem gait task
Measured: Day 2
Tandem Gait Time (seconds)
Seconds to complete the tandem gait task
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Tandem Gait Time (seconds)
Seconds to complete the tandem gait task
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Smooth Pursuit Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Day 2
Smooth Pursuit Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Smooth Pursuit Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Horizontal Saccades Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Day 2
Horizontal Saccades Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Horizontal Saccades Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Vertical Saccades Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Day 2
Vertical Saccades Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Vertical Saccades Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Convergence Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Day 2
Convergence Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Convergence Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Horizontal VOR Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Day 2
Horizontal VOR Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Horizontal VOR Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Vertical VOR Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Day 2
Vertical VOR Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Vertical VOR Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Visual Motion Sensitivity Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Day 2
Visual Motion Sensitivity Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Visual Motion Sensitivity Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Measured: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Secondary outcomes (15)
Pedestrian Collisions (count)
Count of pedestrian collisions during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Speed exceedances (count)
Count of speed exceedances during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Percent time over speed limit (%)
Percent time over speed limit during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Percent time out of lane (%)
Percent time out of lane during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Lateral lane position (feet)
Lateral lane position during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Speed (miles per hour)
Driving speed during a custom STISIM3 driving simulation scenario
Measured: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Number of speeding events (count)
Number of speeding events captured as a naturalistic driving outcomes
Measured: Up to 9 days post-injury
Hard braking events (count)
Hard braking events captured as a naturalistic driving outcomes
Measured: Up to 9 days post-injury
Hard acceleration events (count)
Hard acceleration events captured as a naturalistic driving outcomes
Measured: Up to 9 days post-injury
Hard cornering events (count)
Hard cornering events captured as a naturalistic driving outcomes
Measured: Up to 9 days post-injury
UFOV Processing Speed (ms)
Processing Speed task performance during Useful Field of View Test
Measured: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
UFOV Divided Attention (ms)
Divided attention task performance during Useful Field of View Test
Measured: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
UFOV Selective Attention (ms)
Selective attention task performance during Useful Field of View Test
Measured: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Rey Osterrieth Copy Score (count)
Number of correct items when drawing figure during a Rey Osterrieth copy trial
Measured: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Rey Osterrieth Copy Time (sec)
Time to draw a figure during a Rey Osterrieth copy trial
Measured: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start29 Aug 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies 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
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, University of Kansas, Shepherd Center, Atlanta GA
- Responsible party
- Principal investigator, Julianne Schmidt, University of Georgia
- Investigators
- Julianne Schmidt, PhD, ATC, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942638
- Sponsor's protocol ID
- PROJECT00007249
- Acronym
- LAPDYA
- Status last verified
- Dec 2023
- First submitted
- 28 Apr 2023
- Last updated
- 13 Dec 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Post-concussion Driving in Young Adults
- ClinicalTrials.gov ID
- NCT05942638
- Acronym / sponsor ID
- LAPDYA / PROJECT00007249
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Emory University, University of Kansas, Shepherd Center, Atlanta GA
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Jul 2023 (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.
Upwards of 3.8 million concussions occur annually in the United States. Driving is a highly complicated activity that requires visual, motor, and cognitive skills, which are commonly impaired after concussion. Yet, the time course of post-concussion driving impairment has not been characterized. There is a critical need to 1) determine when concussed individuals should return to driving and 2) identify the key concussion assessment predictors of readiness to return to driving. In the absence of formal recommendations, impaired concussed drivers are at risk to themselves and others on the road.
The first specific aim is to compare simulated driving between concussed individuals and non-concussed yoked matched controls across five longitudinal timepoints (pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance) and daily naturalistic driving from day 2 to day 9.
Driving recommendations must be appropriate and necessitated by concussion impairments, since excessively strict recommendations wrongfully strip concussed patients of their independence and may dissuade individuals from seeking medical care. The second specific aim is to identify widely used concussion assessment outcomes that predict simulated driving performance among concussed individuals throughout concussion recovery.
To address these aims, 100 concussed and 100 yoked matched control young adult college athletes will complete a simulated driving assessment and a robust concussion assessment battery at pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance. Naturalistic driving (measured with in-car global positioning systems) will be captured from day 2 to day 9 (7 days total).
This study will determine the acute and subacute time course of post-concussion driving impairment and determine key predictors of post-concussion driving performance. Results from this innovative approach will have a broad and positive impact that will improve the safety of both concussed individuals and the general population, guide the practices of health professionals, inform the future work of researchers, and substantiate the work of policy-makers by providing evidence-based recommendations for managing post-concussion driving.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussion Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Athletes rostered in an organized sport at the collegiate level
Key inclusion criteria (6 listed)
- 18 years old or older
- Possesses a valid driver's license
- 1 year or more of driving experience
- Normal or corrected-to-normal vision
- Rostered on an organized athletic team at the college level
Key exclusion criteria (7 listed)
- Four or more previous concussions
- A concussion within the past 6 months
- History of any major neurological disorders or injuries
- Current use of any medications that evoke drowsiness (prescription or over the counter)
- Current orthopedic condition that interferes with driving (e.g. a walking boot, shoulder immobilizer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Centerline Crossings (count)
Time frame: Pre-injury baseline
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Centerline Crossings (count)
Time frame: Day 2
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Centerline Crossings (count)
Time frame: Day 4
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Centerline Crossings (count)
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Centerline Crossings (count)
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Road edge excursions (count)
Time frame: Pre-injury baseline
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Road edge excursions (count)
Time frame: Day 2
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Road edge excursions (count)
Time frame: Day 4
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Road edge excursions (count)
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Road edge excursions (count)
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Total Collisions (count)
Time frame: Pre-injury baseline
Count of collisions during a custom STISIM3 driving simulation scenario
Total Collisions (count)
Time frame: Day 2
Count of collisions during a custom STISIM3 driving simulation scenario
Total Collisions (count)
Time frame: Day 4
Count of collisions during a custom STISIM3 driving simulation scenario
Total Collisions (count)
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Count of collisions during a custom STISIM3 driving simulation scenario
Total Collisions (count)
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Count of collisions during a custom STISIM3 driving simulation scenario
Standard Deviation of Lane Position (feet)
Time frame: Pre-injury baseline
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Standard Deviation of Lane Position (feet)
Time frame: Day 2
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Standard Deviation of Lane Position (feet)
Time frame: Day 4
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Standard Deviation of Lane Position (feet)
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Standard Deviation of Lane Position (feet)
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Standard Deviation of speed (miles per hour)
Time frame: Pre-injury baseline
Variability of driving speed during a custom STISIM3 driving simulation scenario
Standard Deviation of speed (miles per hour)
Time frame: Day 2
Variability of driving speed during a custom STISIM3 driving simulation scenario
Standard Deviation of speed (miles per hour)
Time frame: Day 4
Variability of driving speed during a custom STISIM3 driving simulation scenario
Standard Deviation of speed (miles per hour)
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Standard Deviation of speed (miles per hour)
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Number of drives per day (count)
Time frame: Up to 9 days post-injury
Total number of drives per day captured as a naturalistic driving outcomes
Distance travelled per day (miles)
Time frame: Up to 9 days post-injury
Total distance driven per day captured as a naturalistic driving outcomes
Drive time per day (minutes)
Time frame: Up to 9 days post-injury
Total drive time per day captured as a naturalistic driving outcomes
Total symptom severity score
Time frame: Day 2
Total sum of 0-6 ratings across 22 symptom items (SCAT6)
Total symptom severity score
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Total sum of 0-6 ratings across 22 symptom items (SCAT6)
Total symptom severity score
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Total sum of 0-6 ratings across 22 symptom items (SCAT6)
Verbal Memory
Time frame: Day 2
Verbal memory domain score from CNS Vital Signs
Verbal Memory
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Verbal memory domain score from CNS Vital Signs
Verbal Memory
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Verbal memory domain score from CNS Vital Signs
Visual Memory
Time frame: Day 2
Visual memory domain score from CNS Vital Signs
Visual Memory
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Visual memory domain score from CNS Vital Signs
Visual Memory
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Visual memory domain score from CNS Vital Signs
Psychomotor Speed
Time frame: Day 2
Psychomotor speed domain score from CNS Vital Signs
Psychomotor Speed
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Psychomotor speed domain score from CNS Vital Signs
Psychomotor Speed
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Psychomotor speed domain score from CNS Vital Signs
Reaction Time
Time frame: Day 2
Reaction time domain score from CNS Vital Signs
Reaction Time
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Reaction time domain score from CNS Vital Signs
Reaction Time
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Reaction time domain score from CNS Vital Signs
Complex attention
Time frame: Day 2
Complex attention domain score from CNS Vital Signs
Complex attention
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Complex attention domain score from CNS Vital Signs
Complex attention
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Complex attention domain score from CNS Vital Signs
Cognitive Flexibility
Time frame: Day 2
Cognitive flexibility domain score from CNS Vital Signs
Cognitive Flexibility
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Cognitive flexibility domain score from CNS Vital Signs
Cognitive Flexibility
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Cognitive flexibility domain score from CNS Vital Signs
Processing Speed
Time frame: Day 2
Processing speed domain score from CNS Vital Signs
Processing Speed
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Processing speed domain score from CNS Vital Signs
Processing Speed
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Processing speed domain score from CNS Vital Signs
Executive function
Time frame: Day 2
Executive functions domain score from CNS Vital Signs
Executive function
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Executive functions domain score from CNS Vital Signs
Executive function
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Executive functions domain score from CNS Vital Signs
Balance Error Scoring System Total Error Score (count)
Time frame: Day 2
Number of errors committed during the Balance Error Scoring System
Balance Error Scoring System Total Error Score (count)
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Number of errors committed during the Balance Error Scoring System
Balance Error Scoring System Total Error Score (count)
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Number of errors committed during the Balance Error Scoring System
Tandem Gait Time (seconds)
Time frame: Day 2
Seconds to complete the tandem gait task
Tandem Gait Time (seconds)
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Seconds to complete the tandem gait task
Tandem Gait Time (seconds)
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Seconds to complete the tandem gait task
Smooth Pursuit Symptom Rating
Time frame: Day 2
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Smooth Pursuit Symptom Rating
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Smooth Pursuit Symptom Rating
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Horizontal Saccades Symptom Rating
Time frame: Day 2
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Horizontal Saccades Symptom Rating
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Horizontal Saccades Symptom Rating
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Vertical Saccades Symptom Rating
Time frame: Day 2
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Vertical Saccades Symptom Rating
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Vertical Saccades Symptom Rating
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Convergence Symptom Rating
Time frame: Day 2
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Convergence Symptom Rating
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Convergence Symptom Rating
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Horizontal VOR Symptom Rating
Time frame: Day 2
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Horizontal VOR Symptom Rating
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Horizontal VOR Symptom Rating
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Vertical VOR Symptom Rating
Time frame: Day 2
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Vertical VOR Symptom Rating
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Vertical VOR Symptom Rating
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Visual Motion Sensitivity Symptom Rating
Time frame: Day 2
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Visual Motion Sensitivity Symptom Rating
Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Visual Motion Sensitivity Symptom Rating
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
15 secondary outcomes
Pedestrian Collisions (count)
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Speed exceedances (count)
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Percent time over speed limit (%)
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Percent time out of lane (%)
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Lateral lane position (feet)
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Speed (miles per hour)
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Number of speeding events (count)
Time frame: Up to 9 days post-injury
Hard braking events (count)
Time frame: Up to 9 days post-injury
Hard acceleration events (count)
Time frame: Up to 9 days post-injury
Hard cornering events (count)
Time frame: Up to 9 days post-injury
UFOV Processing Speed (ms)
Time frame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
UFOV Divided Attention (ms)
Time frame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
UFOV Selective Attention (ms)
Time frame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Rey Osterrieth Copy Score (count)
Time frame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Rey Osterrieth Copy Time (sec)
Time frame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 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.
Julianne Schmidt, PhD, ATC principal investigator
University of Georgia
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 Brain Injuries, Traumatic and Concussion, Brain, run by University of Georgia 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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 13 Dec 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Centerline Crossings (count) (time frame: Pre-injury baseline). The study lists 82 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 Dec 2023.