[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05942638":3,"trial-entities:NCT05942638":249,"trial-summary:NCT05942638":253},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":16,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":163,"sex":211,"minimum_age":212,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":213,"std_ages":229,"locations":232,"central_contacts":242,"overall_officials":243,"references":247,"see_also_links":248},"NCT05942638","PROJECT00007249","Longitudinal Assessment of Post-concussion Driving in Young Adults","ENROLLING_BY_INVITATION","2028-06","2023-12","2023-12-13","2023-08-29","University of Georgia","OTHER",false,"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.\n\nThe 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.\n\nDriving 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.\n\nTo 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).\n\nThis 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.",null,[18,19,20],"Brain Injuries, Traumatic","Concussion, Brain","Brain Injury Traumatic Mild",[],"OBSERVATIONAL",[],{"count":25,"type":26},1000,"ESTIMATED",[],[29,33,35,37,39,41,44,45,46,47,48,51,52,53,54,55,58,59,60,61,62,65,66,67,68,69,73,76,79,82,83,84,87,88,89,92,93,94,97,98,99,102,103,104,107,108,109,112,113,114,117,118,119,122,123,124,127,128,129,132,133,134,137,138,139,141,142,143,145,146,147,149,150,151,153,154,155,157,158,159,161,162],{"measure":30,"description":31,"timeFrame":32},"Centerline Crossings (count)","Count of centerline crossings during a custom STISIM3 driving simulation scenario","Pre-injury baseline",{"measure":30,"description":31,"timeFrame":34},"Day 2",{"measure":30,"description":31,"timeFrame":36},"Day 4",{"measure":30,"description":31,"timeFrame":38},"Within 24 hours of when symptoms resolve (Asymptomatic) (on average \u003C30 days post-concussion - tracked up to 1 year)",{"measure":30,"description":31,"timeFrame":40},"Within 24 hours of unrestricted medical clearance (on average \u003C30 days post-concussion - tracked up to 1 year)",{"measure":42,"description":43,"timeFrame":32},"Road edge excursions (count)","Count of road edge excursions during a custom STISIM3 driving simulation scenario",{"measure":42,"description":43,"timeFrame":34},{"measure":42,"description":43,"timeFrame":36},{"measure":42,"description":43,"timeFrame":38},{"measure":42,"description":43,"timeFrame":40},{"measure":49,"description":50,"timeFrame":32},"Total Collisions (count)","Count of collisions during a custom STISIM3 driving simulation scenario",{"measure":49,"description":50,"timeFrame":34},{"measure":49,"description":50,"timeFrame":36},{"measure":49,"description":50,"timeFrame":38},{"measure":49,"description":50,"timeFrame":40},{"measure":56,"description":57,"timeFrame":32},"Standard Deviation of Lane Position (feet)","Variability of lateral lane position during a custom STISIM3 driving simulation scenario",{"measure":56,"description":57,"timeFrame":34},{"measure":56,"description":57,"timeFrame":36},{"measure":56,"description":57,"timeFrame":38},{"measure":56,"description":57,"timeFrame":40},{"measure":63,"description":64,"timeFrame":32},"Standard Deviation of speed (miles per hour)","Variability of driving speed during a custom STISIM3 driving simulation scenario",{"measure":63,"description":64,"timeFrame":34},{"measure":63,"description":64,"timeFrame":36},{"measure":63,"description":64,"timeFrame":38},{"measure":63,"description":64,"timeFrame":40},{"measure":70,"description":71,"timeFrame":72},"Number of drives per day (count)","Total number of drives per day captured as a naturalistic driving outcomes","Up to 9 days post-injury",{"measure":74,"description":75,"timeFrame":72},"Distance travelled per day (miles)","Total distance driven per day captured as a naturalistic driving outcomes",{"measure":77,"description":78,"timeFrame":72},"Drive time per day (minutes)","Total drive time per day captured as a naturalistic driving outcomes",{"measure":80,"description":81,"timeFrame":34},"Total symptom severity score","Total sum of 0-6 ratings across 22 symptom items (SCAT6)",{"measure":80,"description":81,"timeFrame":38},{"measure":80,"description":81,"timeFrame":40},{"measure":85,"description":86,"timeFrame":34},"Verbal Memory","Verbal memory domain score from CNS Vital Signs",{"measure":85,"description":86,"timeFrame":38},{"measure":85,"description":86,"timeFrame":40},{"measure":90,"description":91,"timeFrame":34},"Visual Memory","Visual memory domain score from CNS Vital Signs",{"measure":90,"description":91,"timeFrame":38},{"measure":90,"description":91,"timeFrame":40},{"measure":95,"description":96,"timeFrame":34},"Psychomotor Speed","Psychomotor speed domain score from CNS Vital Signs",{"measure":95,"description":96,"timeFrame":38},{"measure":95,"description":96,"timeFrame":40},{"measure":100,"description":101,"timeFrame":34},"Reaction Time","Reaction time domain score from CNS Vital Signs",{"measure":100,"description":101,"timeFrame":38},{"measure":100,"description":101,"timeFrame":40},{"measure":105,"description":106,"timeFrame":34},"Complex attention","Complex attention domain score from CNS Vital Signs",{"measure":105,"description":106,"timeFrame":38},{"measure":105,"description":106,"timeFrame":40},{"measure":110,"description":111,"timeFrame":34},"Cognitive Flexibility","Cognitive flexibility domain score from CNS Vital Signs",{"measure":110,"description":111,"timeFrame":38},{"measure":110,"description":111,"timeFrame":40},{"measure":115,"description":116,"timeFrame":34},"Processing Speed","Processing speed domain score from CNS Vital Signs",{"measure":115,"description":116,"timeFrame":38},{"measure":115,"description":116,"timeFrame":40},{"measure":120,"description":121,"timeFrame":34},"Executive function","Executive functions domain score from CNS Vital Signs",{"measure":120,"description":121,"timeFrame":38},{"measure":120,"description":121,"timeFrame":40},{"measure":125,"description":126,"timeFrame":34},"Balance Error Scoring System Total Error Score (count)","Number of errors committed during the Balance Error Scoring System",{"measure":125,"description":126,"timeFrame":38},{"measure":125,"description":126,"timeFrame":40},{"measure":130,"description":131,"timeFrame":34},"Tandem Gait Time (seconds)","Seconds to complete the tandem gait task",{"measure":130,"description":131,"timeFrame":38},{"measure":130,"description":131,"timeFrame":40},{"measure":135,"description":136,"timeFrame":34},"Smooth Pursuit Symptom Rating","Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening",{"measure":135,"description":136,"timeFrame":38},{"measure":135,"description":136,"timeFrame":40},{"measure":140,"description":136,"timeFrame":34},"Horizontal Saccades Symptom Rating",{"measure":140,"description":136,"timeFrame":38},{"measure":140,"description":136,"timeFrame":40},{"measure":144,"description":136,"timeFrame":34},"Vertical Saccades Symptom Rating",{"measure":144,"description":136,"timeFrame":38},{"measure":144,"description":136,"timeFrame":40},{"measure":148,"description":136,"timeFrame":34},"Convergence Symptom Rating",{"measure":148,"description":136,"timeFrame":38},{"measure":148,"description":136,"timeFrame":40},{"measure":152,"description":136,"timeFrame":34},"Horizontal VOR Symptom Rating",{"measure":152,"description":136,"timeFrame":38},{"measure":152,"description":136,"timeFrame":40},{"measure":156,"description":136,"timeFrame":34},"Vertical VOR Symptom Rating",{"measure":156,"description":136,"timeFrame":38},{"measure":156,"description":136,"timeFrame":40},{"measure":160,"description":136,"timeFrame":34},"Visual Motion Sensitivity Symptom Rating",{"measure":160,"description":136,"timeFrame":38},{"measure":160,"description":136,"timeFrame":40},[164,168,171,174,177,180,183,186,189,192,195,199,202,205,208],{"measure":165,"description":166,"timeFrame":167},"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",{"measure":169,"description":170,"timeFrame":167},"Speed exceedances (count)","Count of speed exceedances during a custom STISIM3 driving simulation scenario",{"measure":172,"description":173,"timeFrame":167},"Percent time over speed limit (%)","Percent time over speed limit during a custom STISIM3 driving simulation scenario",{"measure":175,"description":176,"timeFrame":167},"Percent time out of lane (%)","Percent time out of lane during a custom STISIM3 driving simulation scenario",{"measure":178,"description":179,"timeFrame":167},"Lateral lane position (feet)","Lateral lane position during a custom STISIM3 driving simulation scenario",{"measure":181,"description":182,"timeFrame":167},"Speed (miles per hour)","Driving speed during a custom STISIM3 driving simulation scenario",{"measure":184,"description":185,"timeFrame":72},"Number of speeding events (count)","Number of speeding events captured as a naturalistic driving outcomes",{"measure":187,"description":188,"timeFrame":72},"Hard braking events (count)","Hard braking events captured as a naturalistic driving outcomes",{"measure":190,"description":191,"timeFrame":72},"Hard acceleration events (count)","Hard acceleration events captured as a naturalistic driving outcomes",{"measure":193,"description":194,"timeFrame":72},"Hard cornering events (count)","Hard cornering events captured as a naturalistic driving outcomes",{"measure":196,"description":197,"timeFrame":198},"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",{"measure":200,"description":201,"timeFrame":198},"UFOV Divided Attention (ms)","Divided attention task performance during Useful Field of View Test",{"measure":203,"description":204,"timeFrame":198},"UFOV Selective Attention (ms)","Selective attention task performance during Useful Field of View Test",{"measure":206,"description":207,"timeFrame":198},"Rey Osterrieth Copy Score (count)","Number of correct items when drawing figure during a Rey Osterrieth copy trial",{"measure":209,"description":210,"timeFrame":198},"Rey Osterrieth Copy Time (sec)","Time to draw a figure during a Rey Osterrieth copy trial","ALL","18 Years",{"inclusion":214,"exclusion":220,"raw_text":228},[215,216,217,218,219],"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",[221,222,223,224,225,226,227],"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)","Inclusion Criteria:\n\n* 18 years old or older\n* Possesses a valid driver's license\n* 1 year or more of driving experience\n* Normal or corrected-to-normal vision\n* Rostered on an organized athletic team at the college level\n* (Concussion Group Only) Diagnosed with concussion by a physician and meet inclusion criteria above.\n\nExclusion Criteria:\n\n* Four or more previous concussions\n* A concussion within the past 6 months\n* History of any major neurological disorders or injuries\n* Current use of any medications that evoke drowsiness (prescription or over the counter)\n* Current orthopedic condition that interferes with driving (e.g. a walking boot, shoulder immobilizer)\n* Heavy use of alcohol (binge drinking 5+ days in the past 30 days)\n* Any illegal drug use (any illegal substance use)",[230,231],"ADULT","OLDER_ADULT",[233],{"facility":234,"city":235,"state":236,"zip":237,"country":238,"geoPoint":239},"Ramsey Student Center","Athens","Georgia","30602","United States",{"lat":240,"lon":241},33.96095,-83.37794,[],[244],{"name":245,"affiliation":12,"role":246},"Julianne Schmidt, PhD, ATC","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":250,"biomarkers":252},[251],"Concussion",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]