Longitudinal Assessment of Post-concussion Driving in Young Adults
- Conditions
- Brain Injuries, TraumaticBrain Injury Traumatic MildConcussion, Brain
- Registration Number
- NCT05942638
- Lead Sponsor
- University of Georgia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Road edge excursions (count) 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
Centerline Crossings (count) 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
Total Collisions (count) 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) 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
Number of drives per day (count) Up to 9 days post-injury Total number of drives per day captured as a naturalistic driving outcomes
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 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)
Visual Memory 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
Standard Deviation of speed (miles per hour) 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
Verbal Memory 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
Reaction Time 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 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 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
Executive function 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
Vertical VOR Symptom Rating 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
Psychomotor Speed 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
Processing Speed 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
Tandem Gait Time (seconds) 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 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
Balance Error Scoring System Total Error Score (count) 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
Horizontal Saccades Symptom Rating 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method 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
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
Number of speeding events (count) Up to 9 days post-injury Number of speeding 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
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
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
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
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
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
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
Trial Locations
- Locations (1)
Ramsey Student Center
🇺🇸Athens, Georgia, United States