The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The purpose of this study is to learn more about traumatic brain injury (TBI). Each year, more than 2 million people in the United States seek treatment for TBI, and TBI is a contributing factor in a third of all injury-related U.S. deaths. An estimated 3.2 to 5.3 million people live with the long-term physical, cognitive, and psychological health disabilities caused by TBI, with annual medical costs estimated at more than $76 billion. Although scientists are gaining a better understanding of TBI, so far their advances have not translated into a single successful clinical trial or treatment for acute TBI.

TRACK-TBI is a large, multi-center study that aims to improve both the classification methods for diagnosis of TBI and the evaluation of patient outcomes and clinical practices in order to improve the design of clinical trials. To accomplish this, 3000 participants at 11 U.S. trauma centers will be enrolled in the study and will provide clinical data to support TBI research. The collected data—which will include computed tomography (CT) and magnetic resonance imaging (MRI), blood samples, and de-identified clinical outcome information—will be stored in a publicly accessible group of databases and imaging and biosample repositories collectively called the TBI Information Commons.

Note: Participants must arrive at the emergency department of one of the 11 participating sites within 24 hours of injury to be eligible for the study. 

Study participants will complete 4 research visits, including 3 in-person and 1 telephone visit with researchers, for a total of about 12-14 hours over a period of 12 months.

Researchers hope this study will lead to a better understanding of TBI outcomes and advance TBI clinical research.

Eligibility Criteria:

Inclusion Criteria:

  • Age 18-100 - Documented/verified TBI by ACRM Criteria  Injury occurred within 24 hours of ED arrival
  • Acute brain CT as part of clinical care
  • Visual acuity and hearing adequate for outcomes testing
  • Fluency in English
  • Ability to provide informed consent

Exclusion Criteria:

  • Significant polytrauma that woudl interfere with follow-up and outcome assessment
  • Prisoners or patients in custody
  • Pregnancy in female subjects
  • Patients on psychiatric hold (e.g. 5150, 5250)
  • Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with the validity of outcome assessment due to TBI
  • Major debilitating neurological disease (e.g. stroke, CVA, dementia, tumor) impairing baseline awareness, cognition, or validity of outcome assessment due to TBI
  • Significant history of pre-existing conditions that would interfere with likelihood of follow-up and validity of outcome assessment due to TBI (e.g. major substance abuse, alcoholism, end-stage cancers, learning disabilities, developmental disorders)
  • Contraindications for MR (for CA+MRI cohort)
  • Low likelihood of follow-up (e..g partipant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)
  • Current participant in an interventional trial (e.g. drug, device, behavioral)
  • Non-English speakers as most outcome measures are normed in the English language.

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Study Location:

Multiple U.S. Locations