An observational study in Brain Injuries, Traumatic, Concussion, Brain and Brain Injury Traumatic Mild, sponsored by University of Georgia. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by University of Georgia · Observational
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Georgia is the lead sponsor of 72 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Athletes rostered in an organized sport at the collegiate level
Exclusion Criteria:
Centerline Crossings (count)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Time frame: Pre-injury baseline
Centerline Crossings (count)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Time frame: Day 2
Centerline Crossings (count)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Time frame: Day 4
Centerline Crossings (count)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Time frame: 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
Time frame: 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
Time frame: Pre-injury baseline
Road edge excursions (count)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Time frame: Day 2
Road edge excursions (count)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Time frame: Day 4
Road edge excursions (count)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Time frame: 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
Time frame: 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
Time frame: Pre-injury baseline
Total Collisions (count)
Count of collisions during a custom STISIM3 driving simulation scenario
Time frame: Day 2
Total Collisions (count)
Count of collisions during a custom STISIM3 driving simulation scenario
Time frame: Day 4
Total Collisions (count)
Count of collisions during a custom STISIM3 driving simulation scenario
Time frame: 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
Time frame: 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
Time frame: Pre-injury baseline
Standard Deviation of Lane Position (feet)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Time frame: Day 2
Standard Deviation of Lane Position (feet)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Time frame: Day 4
Standard Deviation of Lane Position (feet)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Time frame: 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
Time frame: 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
Time frame: Pre-injury baseline
Standard Deviation of speed (miles per hour)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Time frame: Day 2
Standard Deviation of speed (miles per hour)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Time frame: Day 4
Standard Deviation of speed (miles per hour)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Time frame: 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
Time frame: 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
Time frame: Up to 9 days post-injury
Distance travelled per day (miles)
Total distance driven per day captured as a naturalistic driving outcomes
Time frame: Up to 9 days post-injury
Drive time per day (minutes)
Total drive time per day captured as a naturalistic driving outcomes
Time frame: Up to 9 days post-injury
Total symptom severity score
Total sum of 0-6 ratings across 22 symptom items (SCAT6)
Time frame: Day 2
Total symptom severity score
Total sum of 0-6 ratings across 22 symptom items (SCAT6)
Time frame: 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)
Time frame: 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
Time frame: Day 2
Verbal Memory
Verbal memory domain score from CNS Vital Signs
Time frame: 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
Time frame: 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
Time frame: Day 2
Visual Memory
Visual memory domain score from CNS Vital Signs
Time frame: 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
Time frame: 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
Time frame: Day 2
Psychomotor Speed
Psychomotor speed domain score from CNS Vital Signs
Time frame: 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
Time frame: 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
Time frame: Day 2
Reaction Time
Reaction time domain score from CNS Vital Signs
Time frame: 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
Time frame: 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
Time frame: Day 2
Complex attention
Complex attention domain score from CNS Vital Signs
Time frame: 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
Time frame: 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
Time frame: Day 2
Cognitive Flexibility
Cognitive flexibility domain score from CNS Vital Signs
Time frame: 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
Time frame: 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
Time frame: Day 2
Processing Speed
Processing speed domain score from CNS Vital Signs
Time frame: 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
Time frame: 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
Time frame: Day 2
Executive function
Executive functions domain score from CNS Vital Signs
Time frame: 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
Time frame: 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
Time frame: Day 2
Balance Error Scoring System Total Error Score (count)
Number of errors committed during the Balance Error Scoring System
Time frame: 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
Time frame: 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
Time frame: Day 2
Tandem Gait Time (seconds)
Seconds to complete the tandem gait task
Time frame: 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
Time frame: 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
Time frame: Day 2
Smooth Pursuit Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Time frame: 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
Time frame: 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
Time frame: Day 2
Horizontal Saccades Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Time frame: 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
Time frame: 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
Time frame: Day 2
Vertical Saccades Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Time frame: 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
Time frame: 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
Time frame: Day 2
Convergence Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Time frame: 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
Time frame: 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
Time frame: Day 2
Horizontal VOR Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Time frame: 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
Time frame: 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
Time frame: Day 2
Vertical VOR Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Time frame: 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
Time frame: 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
Time frame: Day 2
Visual Motion Sensitivity Symptom Rating
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Time frame: 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
Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Pedestrian Collisions (count)
Count of pedestrian collisions during a custom STISIM3 driving simulation scenario
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)
Count of speed exceedances during a custom STISIM3 driving simulation scenario
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 (%)
Percent time over speed limit during a custom STISIM3 driving simulation scenario
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 (%)
Percent time out of lane during a custom STISIM3 driving simulation scenario
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)
Lateral lane position during a custom STISIM3 driving simulation scenario
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)
Driving speed during a custom STISIM3 driving simulation scenario
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)
Number of speeding events captured as a naturalistic driving outcomes
Time frame: Up to 9 days post-injury
Hard braking events (count)
Hard braking events captured as a naturalistic driving outcomes
Time frame: Up to 9 days post-injury
Hard acceleration events (count)
Hard acceleration events captured as a naturalistic driving outcomes
Time frame: Up to 9 days post-injury
Hard cornering events (count)
Hard cornering events captured as a naturalistic driving outcomes
Time frame: Up to 9 days post-injury
UFOV Processing Speed (ms)
Processing Speed task performance during Useful Field of View Test
Time frame: 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
Time frame: 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
Time frame: 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
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 to draw a figure during a Rey Osterrieth copy trial
Time frame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Stop light tickets (count)
Count of stop light tickets during a custom STISIM3 driving simulation scenario
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Stop sign tickets (count)
Count of stop sign tickets during a custom STISIM3 driving simulation scenario
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Turn signal use (count)
Count of turn signal use during a custom STISIM3 driving simulation scenario
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Tailgating (count)
Count of tailgating events during a custom STISIM3 driving simulation scenario
Time frame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Plan to share: Undecided
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University of Georgia