Longitudinal Assessment of Post-concussion Driving in Young Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-29

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Injuries, Traumatic Concussion, Brain Brain Injury Traumatic Mild

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Concussion Group

No interventions assigned to this group

Control Group

No interventions assigned to this group

Eligibility Criteria

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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

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Julianne Schmidt

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julianne Schmidt, PhD, ATC

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

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Ramsey Student Center

Athens, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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PROJECT00007249

Identifier Type: -

Identifier Source: org_study_id