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Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment

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ClinicalTrials.gov Identifier: NCT02278029
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
This study will synthesize a behavioral profile of impaired driving performance for teenage patients with mild traumatic brain injury (mTBI), or concussion, from one week post-concussion to six weeks post-concussion. It will also elucidate the relation between decreased reaction times exhibited by these patients and their functional response to driving hazards. While a few studies have examined driving performance in adult patients with mTBI, to the investigators knowledge this will be the first investigation of driving performance for teenage patients with mTBI. Therefore, it will provide the foundation for the future development of return-to-drive protocols for physicians and clinical practitioners. This study will synthesize a behavioral profile of impaired driving performance for teenage patients with mild traumatic brain injury (mTBI), or concussion, from one week post-concussion to six weeks post-concussion. It will also elucidate the relation between decreased reaction times exhibited by these patients and their functional response to driving hazards. While a few studies have examined driving performance in adult patients with mTBI, to the investigators knowledge this will be the first investigation of driving performance for teenage patients with mTBI. Therefore, it will provide the foundation for the future development of return-to-drive protocols for physicians and clinical practitioners.

Condition or disease
Concussion

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment
Study Start Date : October 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Group/Cohort
Concussed
those subjects with a concussion
Controls
those subjects without a concussion



Primary Outcome Measures :
  1. Number of participants with impaired performance following concussion [ Time Frame: 6 weeks ]

    Patients with mTBI will exhibit more variable speed (greater SD) and more lateral deviation variability from the center lane in all tasks, compared to healthy controls.

    1.2 Patient with mTBI will exhibit more variable speed (greater SD) and more lateral deviation variability from the center lane in all tasks at testing session 1 compared to testing session 2.

    2.1 Patients with mTBI will exhibit longer average response times from the onset of adverse stimuli than healthy controls.

    2.2. Patients with mTBI will exhibit longer average response times from the onset of adverse stimuli at testing session 1 compared to testing session 2.

    3.1 Patients with mTBI will exhibit fewer refixations (less saccades) and longer lag when tracking stimuli for all tasks, compared to healthy controls.

    3.2 Patients with mTBI will exhibit fewer refixations (less saccades) and longer lag when tracking stimuli for all tasks at testing session 1 compared to testing session 2.




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Ages Eligible for Study:   16 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Enrollment of patients with mTBI will take place through our institution's previously established network of outpatient sports medicine clinics. Patients will be defined as those who have suffered closed head trauma diagnosed as mTBI or concussion. We aim to enroll 100 total subjects (50 patients with concussion, 50 control subjects)
Criteria

Inclusion Criteria:

  • Patients will be defined as those who have suffered closed head trauma diagnosed as mTBI or concussion by one of our network's board-certified sports medicine physicians and based on criteria outlined in recent multi-investigator consensus documents37 and including Common Data Elements from the NIH guidelines.

Exclusion Criteria:

  • Subjects will be excluded from the study if they have a history of congenital or acquired cognitive or neurological disorders including developmental delay, brain tumor, stroke, or known pre-injury peripheral or central vestibular disorders. In addition, patients who have begun anti-depressant, stimulant or anti-seizure medications for treatment of their symptoms or for other, unrelated reasons within two months of testing will be excluded from testing. Controls and patients with a pre-injury history of Attention Deficit Hyperactivity Disorder (ADHD) or other issues that could confound their ability to complete the proposed tasks will be documented and utilized for further analyses after completion of testing, but these data will not be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278029


Locations
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United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45209
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Adam Kiefer, PhD Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02278029    
Other Study ID Numbers: 2014-1611
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No