Longitudinal Assessment of Post-concussion Driving in Young Adults (LAPDYA)

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 Overview

• Status: Enrolling by invitation
• Conditions: Brain Injuries, Traumatic; Concussion, Brain; Brain Injury Traumatic Mild

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • Ramsey Student Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Athletes rostered in an organized sport at the collegiate level

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control Group
Concussion Group

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stop light tickets (count)	Count of stop light tickets 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
Stop sign tickets (count)	Count of stop sign tickets 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
Turn signal use (count)	Count of turn signal use 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
Tailgating (count)	Count of tailgating events 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

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: Emory University; University of Kansas; Shepherd Center, Atlanta GA
• Investigators: Principal Investigator: Julianne Schmidt, PhD, ATC, University of Georgia

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: PROJECT00007249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No