Longitudinal Assessment of Post-concussion Driving in Young Adults

Study Overview
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Brief Summary
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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.

Official Title
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Longitudinal Assessment of Post-concussion Driving in Young Adults

Conditions
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Brain Injuries, Traumatic, Concussion, Brain, Brain Injury Traumatic Mild

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Concussion Group<br> | |
| Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Centerline Crossings (count) | Count of centerline crossings during a custom STISIM3 driving simulation scenario | Pre-injury baseline | 
| Centerline Crossings (count) | Count of centerline crossings during a custom STISIM3 driving simulation scenario | Day 2 | 
| Centerline Crossings (count) | Count of centerline crossings during a custom STISIM3 driving simulation scenario | Day 4 | 
| Centerline Crossings (count) | Count of centerline crossings during a custom STISIM3 driving simulation scenario | 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 | 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 | Pre-injury baseline | 
| Road edge excursions (count) | Count of road edge excursions during a custom STISIM3 driving simulation scenario | Day 2 | 
| Road edge excursions (count) | Count of road edge excursions during a custom STISIM3 driving simulation scenario | Day 4 | 
| Road edge excursions (count) | Count of road edge excursions during a custom STISIM3 driving simulation scenario | 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 | 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 | Pre-injury baseline | 
| Total Collisions (count) | Count of collisions during a custom STISIM3 driving simulation scenario | Day 2 | 
| Total Collisions (count) | Count of collisions during a custom STISIM3 driving simulation scenario | Day 4 | 
| Total Collisions (count) | Count of collisions during a custom STISIM3 driving simulation scenario | 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 | 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 | Pre-injury baseline | 
| Standard Deviation of Lane Position (feet) | Variability of lateral lane position during a custom STISIM3 driving simulation scenario | Day 2 | 
| Standard Deviation of Lane Position (feet) | Variability of lateral lane position during a custom STISIM3 driving simulation scenario | Day 4 | 
| Standard Deviation of Lane Position (feet) | Variability of lateral lane position during a custom STISIM3 driving simulation scenario | 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 | 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 | Pre-injury baseline | 
| Standard Deviation of speed (miles per hour) | Variability of driving speed during a custom STISIM3 driving simulation scenario | Day 2 | 
| Standard Deviation of speed (miles per hour) | Variability of driving speed during a custom STISIM3 driving simulation scenario | Day 4 | 
| Standard Deviation of speed (miles per hour) | Variability of driving speed during a custom STISIM3 driving simulation scenario | 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 | 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 | Up to 9 days post-injury | 
| Distance travelled per day (miles) | Total distance driven per day captured as a naturalistic driving outcomes | Up to 9 days post-injury | 
| Drive time per day (minutes) | Total drive time per day captured as a naturalistic driving outcomes | Up to 9 days post-injury | 
| Total symptom severity score | Total sum of 0-6 ratings across 22 symptom items (SCAT6) | Day 2 | 
| Total symptom severity score | Total sum of 0-6 ratings across 22 symptom items (SCAT6) | 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) | 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 | Day 2 | 
| Verbal Memory | Verbal memory domain score from CNS Vital Signs | 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 | 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 | Day 2 | 
| Visual Memory | Visual memory domain score from CNS Vital Signs | 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 | 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 | Day 2 | 
| Psychomotor Speed | Psychomotor speed domain score from CNS Vital Signs | 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 | 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 | Day 2 | 
| Reaction Time | Reaction time domain score from CNS Vital Signs | 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 | 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 | Day 2 | 
| Complex attention | Complex attention domain score from CNS Vital Signs | 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 | 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 | Day 2 | 
| Cognitive Flexibility | Cognitive flexibility domain score from CNS Vital Signs | 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 | 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 | Day 2 | 
| Processing Speed | Processing speed domain score from CNS Vital Signs | 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 | 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 | Day 2 | 
| Executive function | Executive functions domain score from CNS Vital Signs | 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 | 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 | Day 2 | 
| Balance Error Scoring System Total Error Score (count) | Number of errors committed during the Balance Error Scoring System | 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 | 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 | Day 2 | 
| Tandem Gait Time (seconds) | Seconds to complete the tandem gait task | 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 | 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 | Day 2 | 
| Smooth Pursuit Symptom Rating | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening | 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 | 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 | Day 2 | 
| Horizontal Saccades Symptom Rating | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening | 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 | 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 | Day 2 | 
| Vertical Saccades Symptom Rating | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening | 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 | 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 | Day 2 | 
| Convergence Symptom Rating | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening | 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 | 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 | Day 2 | 
| Horizontal VOR Symptom Rating | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening | 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 | 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 | Day 2 | 
| Vertical VOR Symptom Rating | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening | 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 | 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 | Day 2 | 
| Visual Motion Sensitivity Symptom Rating | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening | 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 | Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pedestrian Collisions (count) | Count of pedestrian collisions during a custom STISIM3 driving simulation scenario | 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 | 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 | 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 | 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 | 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 | 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 | Up to 9 days post-injury | 
| Hard braking events (count) | Hard braking events captured as a naturalistic driving outcomes | Up to 9 days post-injury | 
| Hard acceleration events (count) | Hard acceleration events captured as a naturalistic driving outcomes | Up to 9 days post-injury | 
| Hard cornering events (count) | Hard cornering events captured as a naturalistic driving outcomes | Up to 9 days post-injury | 
| UFOV Processing Speed (ms) | Processing Speed task performance during Useful Field of View Test | 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 | 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 | 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 | 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 | Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance |