Traumatic Brain InjuryNCT01132937
Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 886 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Suspected TBI Subjects
- Suspected TBI subjects must meet the following inclusion criteria:
- 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.
Show all 11Show fewer
- Healthy Volunteers
- Healthy volunteers must meet the following inclusion criteria:
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Currently Phase-1 of enrollment for healthy volunteers in the A Beta PET pilot is complete. At this time enrollment of healthy volunteers is on hold until analysis complete. Enrollment of A Beta PET pilot TBI subjects and healthy matches may resume under Phase-2 if analysis of initial data suggests update
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury
- Keywords
- Diffusion/Perfusion - MRI, Magnetic Resonance Imaging (MRI), Stroke, Brain Imaging, Brain Injuries, Natural History
- Medical subject headings
- Brain Injuries, Traumatic, Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intermittently
Secondary outcomes (1)
Success/failure rate for acute MRI in relationship to attempted and those able to undergo CT
Imaging findings on CT in comparison to that of MRI and PET - TBI Outcome Scales
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study start7 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM), United States Department of Defense, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Sponsor
- Investigators
- Lawrence L Latour, Ph.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132937
- Sponsor's protocol ID
- 100122
- Other IDs
- 10-N-0122
- Status last verified
- 3 Jun 2026
- First submitted
- 27 May 2010
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided: Currently we have mechanisms in place to share with CNRM and NIH investigators de-identified data, which is dependent on the individual patient consent to future sharing of data and samples by GUID. Given the language in the consent, the researchers' institute may be a limiting factor to make a IPD as per the guidance from ClinicalTrials.gov
Publications
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.
PubMed 24317693Chiara 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.
PubMed 27215444Rutland-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.
PubMed 17122685Turtzo 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.
PubMed 39999394Baniewicz 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.
PubMed 39088894Davis 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.
PubMed 32614835
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01132937
- Acronym / sponsor ID
- 100122
- Conditions
- Traumatic Brain Injury
- Keywords
- Diffusion/Perfusion - MRI, Magnetic Resonance Imaging (MRI), Stroke, Brain Imaging, Brain Injuries, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM), United States Department of Defense, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 7 Oct 2010 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evidence of injury on MRI of the brain vasculature.
Time frame: Intermittently
Qualitative observations and quantitative measures will be reported and described in relation to history, baseline clinical variables, and TBI outcome scales
1 secondary outcome
Success/failure rate for acute MRI in relationship to attempted and those able to undergo CT
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 24317693Roth 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.
- Background: PubMed 27215444Chiara 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.
- Background: PubMed 17122685Rutland-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.
- Derived from this study: PubMed 39999394Turtzo 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.
- Derived from this study: PubMed 39088894Baniewicz 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.
- Derived from this study: PubMed 32614835Davis 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Currently we have mechanisms in place to share with CNRM and NIH investigators de-identified data, which is dependent on the individual patient consent to future sharing of data and samples by GUID. Given the language in the consent, the researchers' institute may be a limiting factor to make a IPD as per the guidance from ClinicalTrials.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence L Latour, Ph.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of injury on MRI of the brain vasculature. (time frame: Intermittently). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01132937, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.