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NCT05942638

Longitudinal Assessment of Post-concussion Driving in Young Adults

Enrolling by Invitation
Not specifiedAges 18+Observational
University of Georgia
~1,000 participants
Updated 2023-12-13 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Centerline Crossings (count)
Measured over Pre-injury baseline
+81 more outcomes measured

Conditions

Brain Injuries, Traumatic
Concussion, Brain
Brain Injury Traumatic Mild

Explore related trials

Concussion

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Julianne Schmidt, PhD, ATC · PRINCIPAL_INVESTIGATOR · University of Georgia

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • Centerline Crossings (count)Pre-injury baseline

    Count of centerline crossings during a custom STISIM3 driving simulation scenario

  • Centerline Crossings (count)Day 2

    Count of centerline crossings during a custom STISIM3 driving simulation scenario

  • Centerline Crossings (count)Day 4

    Count of centerline crossings during a custom STISIM3 driving simulation scenario

  • Centerline Crossings (count)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

  • 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

  • Road edge excursions (count)Pre-injury baseline

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

  • Road edge excursions (count)Day 2

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

  • Road edge excursions (count)Day 4

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

  • Road edge excursions (count)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

  • 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

  • Total Collisions (count)Pre-injury baseline

    Count of collisions during a custom STISIM3 driving simulation scenario

  • Total Collisions (count)Day 2

    Count of collisions during a custom STISIM3 driving simulation scenario

  • Total Collisions (count)Day 4

    Count of collisions during a custom STISIM3 driving simulation scenario

  • Total Collisions (count)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

  • 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)Pre-injury baseline

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

  • Standard Deviation of Lane Position (feet)Day 2

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

  • Standard Deviation of Lane Position (feet)Day 4

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

  • Standard Deviation of Lane Position (feet)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

  • 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

  • Standard Deviation of speed (miles per hour)Pre-injury baseline

    Variability of driving speed during a custom STISIM3 driving simulation scenario

  • Standard Deviation of speed (miles per hour)Day 2

    Variability of driving speed during a custom STISIM3 driving simulation scenario

  • Standard Deviation of speed (miles per hour)Day 4

    Variability of driving speed during a custom STISIM3 driving simulation scenario

  • Standard Deviation of speed (miles per hour)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

  • 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

  • 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 scoreDay 2

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

  • Total symptom severity scoreWithin 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)

  • Total symptom severity scoreWithin 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)

  • Verbal MemoryDay 2

    Verbal memory domain score from CNS Vital Signs

  • Verbal MemoryWithin 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

  • Verbal MemoryWithin 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

  • Visual MemoryDay 2

    Visual memory domain score from CNS Vital Signs

  • Visual MemoryWithin 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

  • Visual MemoryWithin 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

  • Psychomotor SpeedDay 2

    Psychomotor speed domain score from CNS Vital Signs

  • Psychomotor SpeedWithin 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

  • Psychomotor SpeedWithin 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

  • Reaction TimeDay 2

    Reaction time domain score from CNS Vital Signs

  • Reaction TimeWithin 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

  • Reaction TimeWithin 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 attentionDay 2

    Complex attention domain score from CNS Vital Signs

  • Complex attentionWithin 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

  • Complex attentionWithin 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 FlexibilityDay 2

    Cognitive flexibility domain score from CNS Vital Signs

  • Cognitive FlexibilityWithin 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

  • Cognitive FlexibilityWithin 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

  • Processing SpeedDay 2

    Processing speed domain score from CNS Vital Signs

  • Processing SpeedWithin 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

  • Processing SpeedWithin 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

  • Executive functionDay 2

    Executive functions domain score from CNS Vital Signs

  • Executive functionWithin 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

  • Executive functionWithin 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

  • Balance Error Scoring System Total Error Score (count)Day 2

    Number of errors committed during the Balance Error Scoring System

  • Balance Error Scoring System Total Error Score (count)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

  • 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

  • Tandem Gait Time (seconds)Day 2

    Seconds to complete the tandem gait task

  • Tandem Gait Time (seconds)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

  • 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 RatingDay 2

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

  • Smooth Pursuit Symptom RatingWithin 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

  • Smooth Pursuit Symptom RatingWithin 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 Saccades Symptom RatingDay 2

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

  • Horizontal Saccades Symptom RatingWithin 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

  • Horizontal Saccades Symptom RatingWithin 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 RatingDay 2

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

  • Vertical Saccades Symptom RatingWithin 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

  • Vertical Saccades Symptom RatingWithin 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 RatingDay 2

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

  • Convergence Symptom RatingWithin 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

  • Convergence Symptom RatingWithin 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 RatingDay 2

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

  • Horizontal VOR Symptom RatingWithin 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

  • Horizontal VOR Symptom RatingWithin 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 VOR Symptom RatingDay 2

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

  • Vertical VOR Symptom RatingWithin 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

  • Vertical VOR Symptom RatingWithin 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 RatingDay 2

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

  • Visual Motion Sensitivity Symptom RatingWithin 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

  • Visual Motion Sensitivity Symptom RatingWithin 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