NCT05942638

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Aug 2023Jun 2028

First Submitted

Initial submission to the registry

April 28, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 29, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

4.8 years

First QC Date

April 28, 2023

Last Update Submit

December 6, 2023

Conditions

Brain Injuries, TraumaticConcussion, BrainBrain Injury Traumatic Mild

Outcome Measures

Primary Outcomes (82)

  • 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 Outcomes (15)

  • Pedestrian Collisions (count)

    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)

    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 (%)

    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 (%)

    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)

    Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance

  • +10 more secondary outcomes

Other Outcomes (4)

  • Stop light tickets (count)

    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)

    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)

    Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance

  • +1 more other outcomes

Study Arms (2)

Concussion Group

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Athletes rostered in an organized sport at the collegiate level

You may qualify if:

  • years old or older
  • Possesses a valid driver's license
  • year or more of driving experience
  • Normal or corrected-to-normal vision
  • Rostered on an organized athletic team at the college level

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramsey Student Center

Athens, Georgia, 30602, United States

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Concussion

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Julianne Schmidt, PhD, ATC

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2023

First Posted

July 12, 2023

Study Start

August 29, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

US(1)