Clinical trial NCT05942638: Longitudinal Assessment of Post-concussion Driving in Young Adults
Official title: Longitudinal Assessment of Post-concussion Driving in Young Adults
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Brain Injuries, Traumatic
Concussion, Brain
Brain Injury Traumatic Mild
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: Emory University
name: University of Kansas
name: Shepherd Center, Atlanta GA
First posted: 2023-07-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes rostered in an organized sport at the collegiate level

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Centerline Crossings (count)
timeFrame: Pre-injury baseline
measure: Centerline Crossings (count)
timeFrame: Day 2
measure: Centerline Crossings (count)
timeFrame: Day 4
measure: Centerline Crossings (count)
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Centerline Crossings (count)
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Road edge excursions (count)
timeFrame: Pre-injury baseline
measure: Road edge excursions (count)
timeFrame: Day 2
measure: Road edge excursions (count)
timeFrame: Day 4
measure: Road edge excursions (count)
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Road edge excursions (count)
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Total Collisions (count)
timeFrame: Pre-injury baseline
measure: Total Collisions (count)
timeFrame: Day 2
measure: Total Collisions (count)
timeFrame: Day 4
measure: Total Collisions (count)
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Total Collisions (count)
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Standard Deviation of Lane Position (feet)
timeFrame: Pre-injury baseline
measure: Standard Deviation of Lane Position (feet)
timeFrame: Day 2
measure: Standard Deviation of Lane Position (feet)
timeFrame: Day 4
measure: Standard Deviation of Lane Position (feet)
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Standard Deviation of Lane Position (feet)
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Standard Deviation of speed (miles per hour)
timeFrame: Pre-injury baseline
measure: Standard Deviation of speed (miles per hour)
timeFrame: Day 2
measure: Standard Deviation of speed (miles per hour)
timeFrame: Day 4
measure: Standard Deviation of speed (miles per hour)
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Standard Deviation of speed (miles per hour)
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Number of drives per day (count)
timeFrame: Up to 9 days post-injury
measure: Distance travelled per day (miles)
timeFrame: Up to 9 days post-injury
measure: Drive time per day (minutes)
timeFrame: Up to 9 days post-injury
measure: Total symptom severity score
timeFrame: Day 2
measure: Total symptom severity score
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Total symptom severity score
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Verbal Memory
timeFrame: Day 2
measure: Verbal Memory
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Verbal Memory
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Visual Memory
timeFrame: Day 2
measure: Visual Memory
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Visual Memory
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Psychomotor Speed
timeFrame: Day 2
measure: Psychomotor Speed
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Psychomotor Speed
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Reaction Time
timeFrame: Day 2
measure: Reaction Time
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Reaction Time
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Complex attention
timeFrame: Day 2
measure: Complex attention
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Complex attention
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Cognitive Flexibility
timeFrame: Day 2
measure: Cognitive Flexibility
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Cognitive Flexibility
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Processing Speed
timeFrame: Day 2
measure: Processing Speed
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Processing Speed
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Executive function
timeFrame: Day 2
measure: Executive function
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Executive function
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Balance Error Scoring System Total Error Score (count)
timeFrame: Day 2
measure: Balance Error Scoring System Total Error Score (count)
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Balance Error Scoring System Total Error Score (count)
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Tandem Gait Time (seconds)
timeFrame: Day 2
measure: Tandem Gait Time (seconds)
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Tandem Gait Time (seconds)
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Smooth Pursuit Symptom Rating
timeFrame: Day 2
measure: Smooth Pursuit Symptom Rating
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Smooth Pursuit Symptom Rating
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Horizontal Saccades Symptom Rating
timeFrame: Day 2
measure: Horizontal Saccades Symptom Rating
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Horizontal Saccades Symptom Rating
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Vertical Saccades Symptom Rating
timeFrame: Day 2
measure: Vertical Saccades Symptom Rating
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Vertical Saccades Symptom Rating
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Convergence Symptom Rating
timeFrame: Day 2
measure: Convergence Symptom Rating
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Convergence Symptom Rating
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Horizontal VOR Symptom Rating
timeFrame: Day 2
measure: Horizontal VOR Symptom Rating
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Horizontal VOR Symptom Rating
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Vertical VOR Symptom Rating
timeFrame: Day 2
measure: Vertical VOR Symptom Rating
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Vertical VOR Symptom Rating
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
measure: Visual Motion Sensitivity Symptom Rating
timeFrame: Day 2
measure: Visual Motion Sensitivity Symptom Rating
timeFrame: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)
measure: Visual Motion Sensitivity Symptom Rating
timeFrame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Secondary outcomes:
measure: Pedestrian Collisions (count)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Speed exceedances (count)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Percent time over speed limit (%)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Percent time out of lane (%)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Lateral lane position (feet)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Speed (miles per hour)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Number of speeding events (count)
timeFrame: Up to 9 days post-injury
measure: Hard braking events (count)
timeFrame: Up to 9 days post-injury
measure: Hard acceleration events (count)
timeFrame: Up to 9 days post-injury
measure: Hard cornering events (count)
timeFrame: Up to 9 days post-injury
measure: UFOV Processing Speed (ms)
timeFrame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: UFOV Divided Attention (ms)
timeFrame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: UFOV Selective Attention (ms)
timeFrame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Rey Osterrieth Copy Score (count)
timeFrame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Rey Osterrieth Copy Time (sec)
timeFrame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Other outcomes:
measure: Stop light tickets (count)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Stop sign tickets (count)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Turn signal use (count)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
measure: Tailgating (count)
timeFrame: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance
Locations:
city: Athens
country: United States
facility: Ramsey Student Center
state: Georgia
Study officials:
affiliation: University of Georgia
name: Julianne Schmidt, PhD, ATC
role: PRINCIPAL_INVESTIGATOR
References: