Longitudinal Assessment of Post-concussion Driving in Young Adults

Brain Injuries, Traumatic Clinical Trial

— LAPDYA  

Official title:

Longitudinal Assessment of Post-concussion Driving in Young Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05942638
• Other study ID #: PROJECT00007249
• Status: Enrolling by invitation
• Start date: August 29, 2023
• Est. completion date: June 2028

Study information

• Verified date: December 2023
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Mild
• Concussion, Brain
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Ramsey Student Center	Athens	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
University of Georgia	Emory University, Shepherd Center, Atlanta GA, University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	Centerline Crossings (count)	Count of centerline crossings during a custom STISIM3 driving simulation scenario	Pre-injury baseline
Primary	Centerline Crossings (count)	Count of centerline crossings during a custom STISIM3 driving simulation scenario	Day 2
Primary	Centerline Crossings (count)	Count of centerline crossings during a custom STISIM3 driving simulation scenario	Day 4
Primary	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)
Primary	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)
Primary	Road edge excursions (count)	Count of road edge excursions during a custom STISIM3 driving simulation scenario	Pre-injury baseline
Primary	Road edge excursions (count)	Count of road edge excursions during a custom STISIM3 driving simulation scenario	Day 2
Primary	Road edge excursions (count)	Count of road edge excursions during a custom STISIM3 driving simulation scenario	Day 4
Primary	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)
Primary	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)
Primary	Total Collisions (count)	Count of collisions during a custom STISIM3 driving simulation scenario	Pre-injury baseline
Primary	Total Collisions (count)	Count of collisions during a custom STISIM3 driving simulation scenario	Day 2
Primary	Total Collisions (count)	Count of collisions during a custom STISIM3 driving simulation scenario	Day 4
Primary	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)
Primary	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)
Primary	Standard Deviation of Lane Position (feet)	Variability of lateral lane position during a custom STISIM3 driving simulation scenario	Pre-injury baseline
Primary	Standard Deviation of Lane Position (feet)	Variability of lateral lane position during a custom STISIM3 driving simulation scenario	Day 2
Primary	Standard Deviation of Lane Position (feet)	Variability of lateral lane position during a custom STISIM3 driving simulation scenario	Day 4
Primary	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)
Primary	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)
Primary	Standard Deviation of speed (miles per hour)	Variability of driving speed during a custom STISIM3 driving simulation scenario	Pre-injury baseline
Primary	Standard Deviation of speed (miles per hour)	Variability of driving speed during a custom STISIM3 driving simulation scenario	Day 2
Primary	Standard Deviation of speed (miles per hour)	Variability of driving speed during a custom STISIM3 driving simulation scenario	Day 4
Primary	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)
Primary	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)
Primary	Number of drives per day (count)	Total number of drives per day captured as a naturalistic driving outcomes	Up to 9 days post-injury
Primary	Distance travelled per day (miles)	Total distance driven per day captured as a naturalistic driving outcomes	Up to 9 days post-injury
Primary	Drive time per day (minutes)	Total drive time per day captured as a naturalistic driving outcomes	Up to 9 days post-injury
Primary	Total symptom severity score	Total sum of 0-6 ratings across 22 symptom items (SCAT6)	Day 2
Primary	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)
Primary	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)
Primary	Verbal Memory	Verbal memory domain score from CNS Vital Signs	Day 2
Primary	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)
Primary	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)
Primary	Visual Memory	Visual memory domain score from CNS Vital Signs	Day 2
Primary	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)
Primary	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)
Primary	Psychomotor Speed	Psychomotor speed domain score from CNS Vital Signs	Day 2
Primary	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)
Primary	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)
Primary	Reaction Time	Reaction time domain score from CNS Vital Signs	Day 2
Primary	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)
Primary	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)
Primary	Complex attention	Complex attention domain score from CNS Vital Signs	Day 2
Primary	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)
Primary	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)
Primary	Cognitive Flexibility	Cognitive flexibility domain score from CNS Vital Signs	Day 2
Primary	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)
Primary	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)
Primary	Processing Speed	Processing speed domain score from CNS Vital Signs	Day 2
Primary	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)
Primary	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)
Primary	Executive function	Executive functions domain score from CNS Vital Signs	Day 2
Primary	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)
Primary	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)
Primary	Balance Error Scoring System Total Error Score (count)	Number of errors committed during the Balance Error Scoring System	Day 2
Primary	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)
Primary	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)
Primary	Tandem Gait Time (seconds)	Seconds to complete the tandem gait task	Day 2
Primary	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)
Primary	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)
Primary	Smooth Pursuit Symptom Rating	Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening	Day 2
Primary	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)
Primary	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)
Primary	Horizontal Saccades Symptom Rating	Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening	Day 2
Primary	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)
Primary	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)
Primary	Vertical Saccades Symptom Rating	Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening	Day 2
Primary	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)
Primary	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)
Primary	Convergence Symptom Rating	Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening	Day 2
Primary	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)
Primary	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)
Primary	Horizontal VOR Symptom Rating	Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening	Day 2
Primary	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)
Primary	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)
Primary	Vertical VOR Symptom Rating	Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening	Day 2
Primary	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)
Primary	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)
Primary	Visual Motion Sensitivity Symptom Rating	Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening	Day 2
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of speeding events (count)	Number of speeding events captured as a naturalistic driving outcomes	Up to 9 days post-injury
Secondary	Hard braking events (count)	Hard braking events captured as a naturalistic driving outcomes	Up to 9 days post-injury
Secondary	Hard acceleration events (count)	Hard acceleration events captured as a naturalistic driving outcomes	Up to 9 days post-injury
Secondary	Hard cornering events (count)	Hard cornering events captured as a naturalistic driving outcomes	Up to 9 days post-injury
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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