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.


Objective To generate natural history data for cohort-based comparisons to serve as the basis for hypothesis-driven studies and to contribute to the clinical and physiological understanding of traumatic brain injury (TBI) through the description of manifestations of the injury and the relationship among radiological, hematological, clinical variables and standard functional outcome measures. Study Population One thousand male and female adult subjects with history of recent head injury with or suspected non-penetrating acute TBI, will be enrolled. Subjects having varying degrees of TBI severity will be recruited from the collaborative programs between NIH and non-NIH hospitals. We anticipate approximately 80% of subjects will be classified as mild TBI, concussion, or no injury. Design This is a prospective study of subjects with known and suspected non-penetrating acute traumatic brain injury. Subjects presenting to the emergency department or trauma service at participating hospitals with a history of recent suspected head injury will be studied during the course of their hospital stay and after discharge using radiological, hematological, clinical and functional outcome measures. Subjects will be stratified according to findings and time of initial imaging into cohorts for comparison. The design is intentionally broad in scope to allow acquisition of data for the development of future hypothesis-driven research. Research performed under this protocol will not interfere with standard of care and subjects will not be treated with experimental therapies as part of the research study. Data collected under this research study may be shared without personal identifiers with other researchers if subjects approve this option on the informed consent. Data and samples collected under this protocol and other protocols that allow data sharing will be combined for secondary analysis under this protocol. Outcome Measures A variety of outcome measures will be used including diagnosis, evidence of injury on magnetic resonance imaging (MRI) and positron emission tomography (PET), functional impairment, and quality of life (QOL) assessments. Research questions will focus on a positive diagnosis of brain injury and monitoring the natural history. Statistical analysis plans will be developed as specific research questions and hypotheses are generated.

Eligibility Criteria:

- INCLUSION CRITERIA: Suspected TBI Subjects Suspected TBI subjects must meet the following inclusion criteria: 1. History of acute head injury with or suspected non-penetrating acute TBI 2. Age 18 years or older 3. Deemed medically safe for study participation by the subject s attending physician 4. Able to provide consent or have a legally-authorized representative provide consent. Healthy Volunteers Healthy volunteers must meet the following inclusion criteria: 1. Healthy without past or present history of TBI or other brain disease, as evaluated by medical history and physical exam 2. Age 18 or older. 3. Able to provide informed consent EXCLUSION CRITERIA: Suspected TBI Subjects Suspected TBI subjects are not eligible for participation in this research study if any of the following conditions exist: 1. Considered to be psychiatrically unstable by the patient s attending physician 2. Contraindication to MRI scanning including: pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments. 3. Conditions precluding entry into the scanner such as morbid obesity or claustrophobia or conditions requiring sedation. 4. In female subjects, pregnancy. Healthy Volunteers Healthy volunteers are not eligible for participation in this research study if any of the following conditions exist: 1. Presence of cognitive impairment based on medical history and/or Mini Mental State Examination (MMSE) score of

Study Design:

Study Location:

Multiple U.S. Locations