Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury

NCT01132937 | Completed

• 2 other identifiers: 10012210-N-0122
• Study Type: observational
• Target: 886
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, researchers are interested in developing more standardized criteria for diagnosing and classifying different types of traumatic brain injury. By identifying imaging and other indicators immediately after the injury and during the initial treatment phrase, researchers hope to better understand the nature and effects of acute traumatic brain injury. Objectives:

• To study the MRI results of individuals who have recently had head injury and suspected traumatic brain injury.
• To study the natural evolution of traumatic brain injury for up to 3 months after head injury. Eligibility: \- Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed or suspected traumatic brain injury within the past 48 hours. Design:
• Participants will have one 3-hour study visits: an initial visit (within 48 hours of head injury). Participants may be asked to have an optional 4-day, 30-day, 90-day, and 1-year follow-up.
• Each visit may involve blood samples, an MRI scan (approximately 30 minutes), and a series of tests to evaluate brain function.
• At the optional follow-up visit, participants may have blood samples, an MRI scan, and a general traumatic brain injury assessment.
• This study does not provide treatment and does not replace any current therapies. However, participants who are eligible for other National Institutes of Health studies may be referred to these studies by researchers.

Conditions

Traumatic Brain Injury

Keywords

Diffusion/Perfusion - MRI; Magnetic Resonance Imaging (MRI); Stroke; Brain Imaging; Brain Injuries; Natural History

Outcome Measures

Primary Outcomes (1)

• Evidence of injury on MRI of the brain vasculature.

  Qualitative observations and quantitative measures will be reported and described in relation to history, baseline clinical variables, and TBI outcome scales

  Intermittently

Secondary Outcomes (1)

• Success/failure rate for acute MRI in relationship to attempted and those able to undergo CT

  Ongoing

Study Arms (2)

Healthy Controls

Accrual Ceiling: 20. Healthy, uninjured, subjects are used to match to those suspected of head injury. 10 subjects have been enrolled to date in the PET arm

Suspected of Head Injury

Accrual Ceiling: 1000. Subjects enrolled with 48hrs of suspected head injury in emergency department of local hospitals, Suburban Hospital Center or Washington Hospital Center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enrollment in this protocol will occur at a participating site MedStar Washington Hospital Center (WHC) or Johns Hopkins Suburban Hospital (Suburban). Applicable study procedures will depend on the visit site, diagnostic certainty, and logistic considerations such as ability to be moved to MR suite for imagining in local hospital. All subjects will undergo a study visit at a participating enrollment site with in 48hrs of suspected head injury.

You may qualify if:

• Suspected TBI Subjects
• History of acute head injury with or suspected non-penetrating acute TBI
• Age 18 years or older
• Deemed medically safe for study participation by the subject s attending physician
• Able to provide consent or have a legally-authorized representative provide consent.
• Healthy Volunteers
• Healthy without past or present history of TBI or other brain disease, as evaluated by medical history and physical exam
• Age 18 or older.
• Able to provide informed consent

You may not qualify if:

• Suspected TBI Subjects
• Suspected TBI subjects are not eligible for participation in this research study if any of the following conditions exist:
• Considered to be psychiatrically unstable by the patient s attending physician
• 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.
• Conditions precluding entry into the scanner such as morbid obesity or claustrophobia or conditions requiring sedation.
• In female subjects, pregnancy.
• Healthy Volunteers
• Healthy volunteers are not eligible for participation in this research study if any of the following conditions exist:
• Presence of cognitive impairment based on medical history and/or Mini Mental State Examination (MMSE) score of \< 27
• Current or past DSM-IV diagnosis of a psychiatric disorder including substance use disorder as determined by self-report, medical history, and/or clinical exam
• Major medical problems that can impact brain function (e.g., problems of the CNS including seizures and psychosis; cardiovascular disease including hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report, medical history and/or clinical exam;
• Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a subject s body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the subject s eyes).
• Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
• In female subjects, pregnancy or breastfeeding.
• Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.

Sponsors & Collaborators

• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): lead
• United States Department of Defense: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (6)

• Roth TL, Nayak D, Atanasijevic T, Koretsky AP, Latour LL, McGavern DB. Transcranial amelioration of inflammation and cell death after brain injury. Nature. 2014 Jan 9;505(7482):223-8. doi: 10.1038/nature12808. Epub 2013 Dec 8.

  PMID: 24317693 BACKGROUND

• Chiara Ricciardi M, Bokkers RP, Butman JA, Hammoud DA, Pham DL, Warach S, Latour LL. Trauma-Specific Brain Abnormalities in Suspected Mild Traumatic Brain Injury Patients Identified in the First 48 Hours after Injury: A Blinded Magnetic Resonance Imaging Comparative Study Including Suspected Acute Minor Stroke Patients. J Neurotrauma. 2017 Jan 1;34(1):23-30. doi: 10.1089/neu.2015.4338. Epub 2016 Jun 10.

  PMID: 27215444 BACKGROUND

• Rutland-Brown W, Langlois JA, Thomas KE, Xi YL. Incidence of traumatic brain injury in the United States, 2003. J Head Trauma Rehabil. 2006 Nov-Dec;21(6):544-8. doi: 10.1097/00001199-200611000-00009.

  PMID: 17122685 BACKGROUND

• Turtzo LC, Chapagain NY, Peterkin N, Cota MR, Vorn R, Devoto C, O'Keefe J, Emanuel OM, Parikh G, Diaz-Arrastia R, Butman JA, McGavern DB, Chan L, Latour LL. Association of Traumatic Meningeal Enhancement on MRI With Clinical Recovery in Patients With Traumatic Brain Injury. Neurology. 2025 Mar 25;104(6):e213448. doi: 10.1212/WNL.0000000000213448. Epub 2025 Feb 25.

  PMID: 39999394 DERIVED

• Baniewicz E, Peterkin N, Luby M, Kern KC, Gottesman RF, Latour LL, Turtzo LC. Age-associated gadolinium leakage into ocular structures in patients with acute traumatic brain injury. J Neurol Sci. 2024 Aug 15;463:123149. doi: 10.1016/j.jns.2024.123149. Epub 2024 Jul 22.

  PMID: 39088894 DERIVED

• Davis TS, Nathan JE, Tinoco Martinez AS, De Vis JB, Turtzo LC, Latour LL. -----Comparison of T1-Post and FLAIR-Post MRI for identification of traumatic meningeal enhancement in traumatic brain injury patients. PLoS One. 2020 Jul 2;15(7):e0234881. doi: 10.1371/journal.pone.0234881. eCollection 2020.

  PMID: 32614835 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lawrence L Latour, Ph.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: October 7, 2010
• Last Updated: April 29, 2026

Record last verified: 2025-06-18

Locations

US (1)