Longitudinal Assessment of Post-concussion Driving in Young Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brain Injuries, Traumatic, Concussion, Brain, Brain Injury Traumatic Mild. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Centerline Crossings (count) [Time frame: Pre-injury baseline]
- Centerline Crossings (count) [Time frame: Day 2]
- Centerline Crossings (count) [Time frame: Day 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)]
- Centerline Crossings (count) [Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)]
- Road edge excursions (count) [Time frame: Pre-injury baseline]
- Road edge excursions (count) [Time frame: Day 2]
- Road edge excursions (count) [Time frame: Day 4]
- 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)]
- Road edge excursions (count) [Time frame: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)]
Secondary outcome measures (12)
- 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]
- 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]
- 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 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]
- 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]
- 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]
- Number of speeding events (count) [Time frame: Up to 9 days post-injury]
- Hard braking events (count) [Time frame: Up to 9 days post-injury]
- Hard acceleration events (count) [Time frame: Up to 9 days post-injury]
- Hard cornering events (count) [Time frame: Up to 9 days post-injury]
- UFOV Processing Speed (ms) [Time frame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]
- UFOV Divided Attention (ms) [Time frame: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Ramsey Student Center — Athens
Identifiers
NCT: NCT05942638 · PROJECT00007249