Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment

NCT02278029 | Completed DMC

• 1 other identifier: 2014-1611
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion

Outcome Measures

Primary Outcomes (1)

• Number of participants with impaired performance following concussion

  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.

  6 weeks

Study Arms (2)

Concussed

those subjects with a concussion

Controls

those subjects without a concussion

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45209, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Adam Kiefer, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 29, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)