Brain Injuries, Traumatic, Brain Injury Traumatic Mild, Concussion, Brain
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Emory University
University of Kansas
Shepherd Center, Atlanta GA
University of Georgia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Motion Sensitivity Symptom Rating | Day 2 | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening |
| Distance travelled per day (miles) | Up to 9 days post-injury | Total distance driven per day captured as a naturalistic driving outcomes |
| Drive time per day (minutes) | Up to 9 days post-injury | Total drive time per day captured as a naturalistic driving outcomes |
| Total symptom severity score | Day 2 | Total sum of 0-6 ratings across 22 symptom items (SCAT6) |
| Verbal Memory | Day 2 | Verbal memory domain score from CNS Vital Signs |
| Visual Memory | Day 2 | Visual memory domain score from CNS Vital Signs |
| Psychomotor Speed | Day 2 | Psychomotor speed domain score from CNS Vital Signs |
| Reaction Time | Day 2 | Reaction time domain score from CNS Vital Signs |
| Complex attention | Day 2 | Complex attention domain score from CNS Vital Signs |
| Cognitive Flexibility | Day 2 | Cognitive flexibility domain score from CNS Vital Signs |
| Processing Speed | Day 2 | Processing speed domain score from CNS Vital Signs |
| Executive function | Day 2 | Executive functions domain score from CNS Vital Signs |
| Balance Error Scoring System Total Error Score (count) | Day 2 | Number of errors committed during the Balance Error Scoring System |
| Tandem Gait Time (seconds) | Day 2 | Seconds to complete the tandem gait task |
| Smooth Pursuit Symptom Rating | Day 2 | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening |
| Horizontal Saccades Symptom Rating | Day 2 | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening |
| Vertical Saccades Symptom Rating | Day 2 | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening |
| Convergence Symptom Rating | Day 2 | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening |
| Horizontal VOR Symptom Rating | Day 2 | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening |
| Vertical VOR Symptom Rating | Day 2 | Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening |
| Centerline Crossings (count) | Pre-injury baseline | Count of centerline crossings during a custom STISIM3 driving simulation scenario |
| Road edge excursions (count) | Pre-injury baseline | Count of road edge excursions during a custom STISIM3 driving simulation scenario |
| Total Collisions (count) | Pre-injury baseline | Count of collisions during a custom STISIM3 driving simulation scenario |
| Standard Deviation of Lane Position (feet) | Pre-injury baseline | Variability of lateral lane position during a custom STISIM3 driving simulation scenario |
| Standard Deviation of speed (miles per hour) | Pre-injury baseline | Variability of driving speed during a custom STISIM3 driving simulation scenario |
| Number of drives per day (count) | Up to 9 days post-injury | Total number of drives per day captured as a naturalistic driving outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UFOV Selective Attention (ms) | Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Selective attention task performance during Useful Field of View Test |
| Rey Osterrieth Copy Score (count) | Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Number of correct items when drawing figure during a Rey Osterrieth copy trial |
| Rey Osterrieth Copy Time (sec) | Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Time to draw a figure during a Rey Osterrieth copy trial |
| Pedestrian Collisions (count) | Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Count of pedestrian collisions during a custom STISIM3 driving simulation scenario |
| Speed exceedances (count) | Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Count of speed exceedances during a custom STISIM3 driving simulation scenario |
| Percent time over speed limit (%) | 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 during a custom STISIM3 driving simulation scenario |
| Percent time out of lane (%) | 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 during a custom STISIM3 driving simulation scenario |
| Lateral lane position (feet) | 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 during a custom STISIM3 driving simulation scenario |
| Speed (miles per hour) | Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Driving speed during a custom STISIM3 driving simulation scenario |
| Number of speeding events (count) | Up to 9 days post-injury | Number of speeding events captured as a naturalistic driving outcomes |
| Hard braking events (count) | Up to 9 days post-injury | Hard braking events captured as a naturalistic driving outcomes |
| Hard acceleration events (count) | Up to 9 days post-injury | Hard acceleration events captured as a naturalistic driving outcomes |
| Hard cornering events (count) | Up to 9 days post-injury | Hard cornering events captured as a naturalistic driving outcomes |
| UFOV Processing Speed (ms) | Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Processing Speed task performance during Useful Field of View Test |
| UFOV Divided Attention (ms) | Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Divided attention task performance during Useful Field of View Test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stop light tickets (count) | Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Count of stop light tickets during a custom STISIM3 driving simulation scenario |
| Turn signal use (count) | Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Count of turn signal use during a custom STISIM3 driving simulation scenario |
| Tailgating (count) | Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Count of tailgating events during a custom STISIM3 driving simulation scenario |
| Stop sign tickets (count) | Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance | Count of stop sign tickets during a custom STISIM3 driving simulation scenario |
Countries
United States
Outcome results
None listed