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Enrolling by Invitation

NCT Number: NCT05942638

Longitudinal Assessment of Post-concussion Driving in Young Adults

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.

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Key information

Conditions

Brain Injuries, Traumatic Brain Concussion Brain Diseases Brain Injuries Brain Injury Traumatic Mild Central Nervous System Diseases Concussion, Brain Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ramsey Student Center

Athens, Georgia, 30602, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Centerline Crossings (count)

    Time frame: Pre-injury baseline

    Count of centerline crossings during a custom STISIM3 driving simulation scenario

  2. Centerline Crossings (count)

    Time frame: Day 2

    Count of centerline crossings during a custom STISIM3 driving simulation scenario

  3. Centerline Crossings (count)

    Time frame: Day 4

    Count of centerline crossings during a custom STISIM3 driving simulation scenario

  4. Centerline Crossings (count)

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Count of centerline crossings during a custom STISIM3 driving simulation scenario

  5. Centerline Crossings (count)

    Time frame: 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

  6. Road edge excursions (count)

    Time frame: Pre-injury baseline

    Count of road edge excursions during a custom STISIM3 driving simulation scenario

  7. Road edge excursions (count)

    Time frame: Day 2

    Count of road edge excursions during a custom STISIM3 driving simulation scenario

  8. Road edge excursions (count)

    Time frame: Day 4

    Count of road edge excursions during a custom STISIM3 driving simulation scenario

  9. Road edge excursions (count)

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Count of road edge excursions during a custom STISIM3 driving simulation scenario

  10. Road edge excursions (count)

    Time frame: 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

  11. Total Collisions (count)

    Time frame: Pre-injury baseline

    Count of collisions during a custom STISIM3 driving simulation scenario

  12. Total Collisions (count)

    Time frame: Day 2

    Count of collisions during a custom STISIM3 driving simulation scenario

  13. Total Collisions (count)

    Time frame: Day 4

    Count of collisions during a custom STISIM3 driving simulation scenario

  14. Total Collisions (count)

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Count of collisions during a custom STISIM3 driving simulation scenario

  15. Total Collisions (count)

    Time frame: 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

  16. Standard Deviation of Lane Position (feet)

    Time frame: Pre-injury baseline

    Variability of lateral lane position during a custom STISIM3 driving simulation scenario

  17. Standard Deviation of Lane Position (feet)

    Time frame: Day 2

    Variability of lateral lane position during a custom STISIM3 driving simulation scenario

  18. Standard Deviation of Lane Position (feet)

    Time frame: Day 4

    Variability of lateral lane position during a custom STISIM3 driving simulation scenario

  19. Standard Deviation of Lane Position (feet)

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Variability of lateral lane position during a custom STISIM3 driving simulation scenario

  20. Standard Deviation of Lane Position (feet)

    Time frame: 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

  21. Standard Deviation of speed (miles per hour)

    Time frame: Pre-injury baseline

    Variability of driving speed during a custom STISIM3 driving simulation scenario

  22. Standard Deviation of speed (miles per hour)

    Time frame: Day 2

    Variability of driving speed during a custom STISIM3 driving simulation scenario

  23. Standard Deviation of speed (miles per hour)

    Time frame: Day 4

    Variability of driving speed during a custom STISIM3 driving simulation scenario

  24. Standard Deviation of speed (miles per hour)

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Variability of driving speed during a custom STISIM3 driving simulation scenario

  25. Standard Deviation of speed (miles per hour)

    Time frame: 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

  26. Number of drives per day (count)

    Time frame: Up to 9 days post-injury

    Total number of drives per day captured as a naturalistic driving outcomes

  27. Distance travelled per day (miles)

    Time frame: Up to 9 days post-injury

    Total distance driven per day captured as a naturalistic driving outcomes

  28. Drive time per day (minutes)

    Time frame: Up to 9 days post-injury

    Total drive time per day captured as a naturalistic driving outcomes

  29. Total symptom severity score

    Time frame: Day 2

    Total sum of 0-6 ratings across 22 symptom items (SCAT6)

  30. Total symptom severity score

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Total sum of 0-6 ratings across 22 symptom items (SCAT6)

  31. Total symptom severity score

    Time frame: 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)

  32. Verbal Memory

    Time frame: Day 2

    Verbal memory domain score from CNS Vital Signs

  33. Verbal Memory

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Verbal memory domain score from CNS Vital Signs

  34. Verbal Memory

    Time frame: 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

  35. Visual Memory

    Time frame: Day 2

    Visual memory domain score from CNS Vital Signs

  36. Visual Memory

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Visual memory domain score from CNS Vital Signs

  37. Visual Memory

    Time frame: 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

  38. Psychomotor Speed

    Time frame: Day 2

    Psychomotor speed domain score from CNS Vital Signs

  39. Psychomotor Speed

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Psychomotor speed domain score from CNS Vital Signs

  40. Psychomotor Speed

    Time frame: 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

  41. Reaction Time

    Time frame: Day 2

    Reaction time domain score from CNS Vital Signs

  42. Reaction Time

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Reaction time domain score from CNS Vital Signs

  43. Reaction Time

    Time frame: 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

  44. Complex attention

    Time frame: Day 2

    Complex attention domain score from CNS Vital Signs

  45. Complex attention

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Complex attention domain score from CNS Vital Signs

  46. Complex attention

    Time frame: 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

  47. Cognitive Flexibility

    Time frame: Day 2

    Cognitive flexibility domain score from CNS Vital Signs

  48. Cognitive Flexibility

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Cognitive flexibility domain score from CNS Vital Signs

  49. Cognitive Flexibility

    Time frame: 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

  50. Processing Speed

    Time frame: Day 2

    Processing speed domain score from CNS Vital Signs

  51. Processing Speed

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Processing speed domain score from CNS Vital Signs

  52. Processing Speed

    Time frame: 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

  53. Executive function

    Time frame: Day 2

    Executive functions domain score from CNS Vital Signs

  54. Executive function

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Executive functions domain score from CNS Vital Signs

  55. Executive function

    Time frame: 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

  56. Balance Error Scoring System Total Error Score (count)

    Time frame: Day 2

    Number of errors committed during the Balance Error Scoring System

  57. Balance Error Scoring System Total Error Score (count)

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Number of errors committed during the Balance Error Scoring System

  58. Balance Error Scoring System Total Error Score (count)

    Time frame: 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

  59. Tandem Gait Time (seconds)

    Time frame: Day 2

    Seconds to complete the tandem gait task

  60. Tandem Gait Time (seconds)

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)

    Seconds to complete the tandem gait task

  61. Tandem Gait Time (seconds)

    Time frame: 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

  62. Smooth Pursuit Symptom Rating

    Time frame: Day 2

    Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening

  63. Smooth Pursuit Symptom Rating

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (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

  64. Smooth Pursuit Symptom Rating

    Time frame: 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

  65. Horizontal Saccades Symptom Rating

    Time frame: Day 2

    Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening

  66. Horizontal Saccades Symptom Rating

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (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

  67. Horizontal Saccades Symptom Rating

    Time frame: 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

  68. Vertical Saccades Symptom Rating

    Time frame: Day 2

    Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening

  69. Vertical Saccades Symptom Rating

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (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

  70. Vertical Saccades Symptom Rating

    Time frame: 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

  71. Convergence Symptom Rating

    Time frame: Day 2

    Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening

  72. Convergence Symptom Rating

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (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

  73. Convergence Symptom Rating

    Time frame: 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

  74. Horizontal VOR Symptom Rating

    Time frame: Day 2

    Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening

  75. Horizontal VOR Symptom Rating

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (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

  76. Horizontal VOR Symptom Rating

    Time frame: 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

  77. Vertical VOR Symptom Rating

    Time frame: Day 2

    Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening

  78. Vertical VOR Symptom Rating

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (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

  79. Vertical VOR Symptom Rating

    Time frame: 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

  80. Visual Motion Sensitivity Symptom Rating

    Time frame: Day 2

    Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening

  81. Visual Motion Sensitivity Symptom Rating

    Time frame: Within 24 hours of when symptoms resolve (Asymptomatic) (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

  82. Visual Motion Sensitivity Symptom Rating

    Time frame: 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 outcomes

  1. Pedestrian Collisions (count)

    Time frame: 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

  2. Speed exceedances (count)

    Time frame: 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

  3. Percent time over speed limit (%)

    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 during a custom STISIM3 driving simulation scenario

  4. Percent time out of lane (%)

    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 during a custom STISIM3 driving simulation scenario

  5. Lateral lane position (feet)

    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 during a custom STISIM3 driving simulation scenario

  6. Speed (miles per hour)

    Time frame: 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

  7. Number of speeding events (count)

    Time frame: Up to 9 days post-injury

    Number of speeding events captured as a naturalistic driving outcomes

  8. Hard braking events (count)

    Time frame: Up to 9 days post-injury

    Hard braking events captured as a naturalistic driving outcomes

  9. Hard acceleration events (count)

    Time frame: Up to 9 days post-injury

    Hard acceleration events captured as a naturalistic driving outcomes

  10. Hard cornering events (count)

    Time frame: Up to 9 days post-injury

    Hard cornering events captured as a naturalistic driving outcomes

  11. UFOV Processing Speed (ms)

    Time frame: 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

  12. UFOV Divided Attention (ms)

    Time frame: 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

  13. UFOV Selective Attention (ms)

    Time frame: 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

  14. Rey Osterrieth Copy Score (count)

    Time frame: 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

  15. Rey Osterrieth Copy Time (sec)

    Time frame: 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

Other outcomes

  1. Stop light tickets (count)

    Time frame: 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

  2. Stop sign tickets (count)

    Time frame: 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

  3. Turn signal use (count)

    Time frame: 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

  4. Tailgating (count)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • Emory University
  • Shepherd Center, Atlanta GA
  • University of Kansas

Registry information

Acronym: LAPDYA

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 12, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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