TBI in the News

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Study 1:

Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT) (PIs: Stephen Wisniewski, Ph.D., and Michael J Bell, MD)

ADAPT is an international research study designed to evaluate the impact of interventions on the outcomes of children with severe traumatic brain injury. The study was funded by the National Institutes of Neurological Disorders and Stroke (1 U01 NS081041-01A1).   

The study tested three aims:   

Specific Aim 1: Compare the effectiveness of first-line intracranial hypertension strategies.  

Specific Aim 2: Compare the effectiveness of strategies that mitigate iatrogenic ischemia and hypoxia.  

Specific Aim 3: Compare the effectiveness of strategies that provide metabolic support on outcome.  

40 clinical assessment form structures totaling 20,335 data records for 1000 subjects are now available in the FITBIR Data Repository. Imaging data will be shared at a later date.  

For more study information, please visit the site: https://www.adapttrial.org/  

The study profile for ADAPT in FITBIR can be found at: https://fitbir.nih.gov/study_profile/231  

Summary Information:

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Study 2:

Chronic Effects of Neurotrauma Consortium (CENC) Study 08: Otolith Dysfunction and Postural Stability (Principal Investigator:  Faith Akin, PhD)

Chronic Effects of Neurotrauma Consortium (CENC) Study 08: Otolith Dysfunction and Postural Stability is a prospective case-controlled study to determine the effect of inner ear (vestibular) dysfunction on balance, gait and quality of life in Veterans. The specific aims are designed to determine the effect of otolith dysfunction on postural stability at the levels of impairment (Specific Aim 1), activity and participation (Specific Aim 2), and determine the interaction of age and otolith dysfunction on postural stability (Specific Aim 3). Balance measures, gait and mobility measures and self-report questionnaires were compared between vestibular groups and across a wide age range.

The study profile for the CENC Study 08 in FITBIR can be found here.

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Study 3:

MicroRNA in cerebral spinal fluid as biomarkers of Alzheimer's disease risk after brain injury (PI: Joseph Quinn, M.D.)

Traumatic brain injury (TBI) is a risk factor for Alzheimer's disease (AD), the most common neurodegenerative disease and a major public health problem. The mechanistic link between TBI and AD is not clear, and there is a long latency between TBI and AD, during which individuals are largely asymptomatic. The clinician's ultimate goal is to define interventions to reduce the risk of AD associated with TBI, but this will require definition of biomarkers of disease activity, especially during the prolonged latent period between the TBI and onset of dementia. While a variety of candidate biomarkers exist, the recent discovery of extracellular microRNAs in cerebrospinal fluid represents an opportunity to rapidly define candidate biomarkers of TBI and TBI-associated neurodegeneration.

To identify biomarkers specific to TBI, we examined miRNA expression in banked CSF obtained from and representing 3 groups: (i) deployed Iraq/Afghanistan Veterans who suffered repetitive blast mTBI, (ii) deployed Veterans with no lifetime history of TBI, and (iii) age-matched community controls with no lifetime history of TBI to identify whether miRNAs are dysregulated as a consequence of brain injury.

The study profile in FITBIR can be found here.

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Study 1:

Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury (TEAM-TBI) (Principal Investigator: David O Okonkwo, MD, PhD)

TEAM-TBI is a research study that ran from 2014-2018 and brought together TBI patients, advanced evaluation methods, and clinical experts in a multi-faceted study to address the heterogeneity of TBI and the effects of targeted rehabilitation, interventional, and social strategies have on TBI outcomes. The study involved a comprehensive 3-4 day intake evaluation and a multi-disciplinary adjudication of clinical profiles, followed by targeted therapies during a 6-9 month follow-up period. The interventions were individualized to each participant based on intake evaluations and reviewed by investigators specialized in each trajectory (i.e. cognitive therapy, vestibular therapy, sleep therapy, etc.). Participants were monitored during the remote portion via telemonitoring and telemedicine modalities, and returned after approximately 6 months for a follow-up to their initial assessment. Study data in the FITBIR repository includes numerous clinical assessments as well as MRI and MEG.

The study profile for the TEAM-TBI Study in FITBIR can be found here.

Summary Information:

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Study 2:

Cognitive rehabilitation: ACTION training for soldiers with executive dysfunction (Principal Investigator: Mary Vining Radomski, PhD, OTR/L)

This study evaluated the feasibility (acceptability, implementability, and preliminary impact) of a one-to-one, 8-session metacognitive strategy instruction (MSI) intervention that incorporated training in implementation intentions (II) called ACTION (AutomatiC iniTiation of IntentiONs). Thirty-eight consenting soldiers with mild traumatic brain injury-symptom complex who were referred to cognitive rehabilitation at the Fort Campbell Intrepid Spirit (FCIS) were randomized to the ACTION condition (MSI plus II) or to MSI-alone; 34 completed the study. Responses from a post-test experience survey suggest that the ACTION intervention was acceptable to those who received it. Both the manualized ACTION and MSI-alone interventions were implementable (mean of 98.31% of the 113 elements administered across ACTION participants; 99% of 78 elements for MSI-alone). All sessions were 60 minutes in duration. Overall, SM who received ACTION were able to learn to write II for self- selected goals. Thirteen of the 16 SM in ACTION met criteria for II competence (achieving >=80% of correctness points). SM who received ACTION demonstrated statistically significant pre-post changes in implementing a goal behavior (shifting) in a novel task (p=0.005) at posttest; those in the control condition did not (p=0.210). Goal achievement appeared to be influenced by nature of goals, group assignment, homework adherence.  Further study is warranted.

The study profile in FITBIR can be found here.

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Study 3:

Development and Validation of the Virtual Environment TBI Screen (VETS) for Postural Control Testing (Principal Investigator: Geoffrey Wright, PhD)

This study evaluated the validity of the Virtual Environment Traumatic brain injury (TBI) Screen (VETS) as a new assessment tool that can potentially be used to measure postural stability in healthy and neurologically impaired individuals. Study participants performed standing postural tasks using the VETS, clinical examination and neurocognitive tests.

The study profile in FITBIR can be found here.

Summary Information:

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Study 1:

Integrating Traumatic Brain Injury Model Systems Data into the Federal Interagency Traumatic Brain Injury Research Informatics System (Principal Investigator: Cynthia Harrison-Felix, Ph.D)

Traumatic Brain Injury Model Systems is the first prospective, longitudinal multi-center study ever conducted which examines the course of recovery and outcomes following the delivery of a coordinated system of acute neurotrauma and inpatient rehabilitation. The study started in 1989 and has enrolled over 12,000 adult study participants with moderate to severe TBI. The data from study participants (N = 14,152) include preinjury, injury, acute care, rehabilitation, and outcomes at 1, 2, and 5 years post-injury. Currently, the Data Repository consists of data that spans from the beginning of the study to the year 2015. Study data within the Repository will be updated as additional data becomes available to FITBIR.

Additional information about the study can be found at https://www.tbindsc.org/ .

The study profile for the TBIMS Study in FITBIR can be found here.

Summary Information:

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Study 2:

Automated Comprehensive Evaluation of Mild Traumatic Brain Injury Visual Dysfunction (Principal Investigator: Jose Capo-Aponte, Ph.D.)

This study expanded on previous studies completed by Dr. Capo-Aponte which includes a 2012 computerized oculomotor and vision screening (COVS) study of mTBI (Capo-Aponte et al. 2012) and the 2014 article titled "Proposed objective visual system biomarkers for mild traumatic brain injury" by Ciuffreda and Capo-Aponte et al. (Ciuffreda et al. 2014). Study data is comprised of 15 clinical assessments for active duty personnel (N=120). The purpose of this study is to validate the Neuro-Ophthalmic Device (NODe) test battery that provides the highest sensitivity and specificity for the detection of oculomotor and high order visual processing dysfunctions on a large population of Warfighters with acute mTBI as compared to healthy age-matched controls.

The study profile for this study can be found here.

Summary Information:

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1,555 subject participants

94 clinical research forms

264,765 data points

 6,451 MRI scans of exposed and unexposed participants

William Walker, MD from Virginia Commonwealth University (VCU) and the Hunter Holmes McGuire VA Medical Center (Richmond, VA), has successfully submitted data to the Federal Interagency Traumatic Brain Injury Research (FITBIR) for his Chronic Effects of Neurotrauma Consortium (CENC) Study 01: Observational Study on Late Neurologic Effects of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Combat. The funding for this study was through the U.S. Army Medical Research and Development Command (W81XWH-13-2-0095) and the U.S. Department of Veterans Affairs  Office of Research and Development (I01 CX001135 and other awards).  Clinical assessement data from this study is now available in the FITBIR informatics system as of October 9, 2020.  The neuroimaging data will be available at a later time.

CENC Cycle 1 (2013-2019) was Study 01: Observational Study on Late Neurologic Effects of OEF/OIF/OND Combat, which enrolled current and former U.S. service members with varying histories of mTBI from no exposure to more than 15, from 7 VA Medical Centers and 1 Military Treatment Facility around the country. The incredibly rich data amassed from the first 1555 participants who were enrolled and evaluated (i.e., completed the minimum set of assessments) are now available to the scientific community.

Additional study information can be found here: https://www.limbic-cenc.org/.

The study profile for the CENC Study 01 in FITBIR can be found here: https://fitbir.nih.gov/study_profile/263.


On August 5th, 2020, the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System received CoreTrustSeal Certification.

What is CoreTrustSeal certification?

It is a certification based on requirements established by the World Data Systems (WDS) and the Data Seal of Approval (DSA) reflecting the core characteristics of trustworthy data repositories. CoreTrustSeal certification is a process whereby a data repository provides evidence it is sustainable and trustworthy via an online application. Evidence must be presented for 16 Requirements which span background, organizational infrastructure (mission, continuity of access, sustainability), digital object management (integrity, authenticity, storage, preservation, quality, identifiers, re-use), and technology (technical infrastructure and security) information. Applicants indicate a compliance level for each requirement, as well as, evidence in support of the requirement. To learn more about the requirements for certification, click here.

What are the benefits of being a certified repository?

  • Enhances the reputation of the repository
  • Builds stakeholder confidence establishing trust for both data funders, depositors, and users
  • Data Funders: Data reuse yields a higher return on investment.
  • Data Depositors: Data is well structured, safe, accessible, and usable.
  • Data Users: Data is high quality and properly preserved.
  • Increases awareness of and compliance with established standards

Statistics |FITBIR CoreTrustSeal (CTS) certification

  • One of (95) repositories globally
  • 1 of 2 CTS repositories at NIH


The certification for FITBIR is valid for 3 years.


FITBIR Update (3/2/20) | Concussion Assessment, Research and Education (CARE) Consortium

The CARE Study Team has provided the following guidance on the datasets shared between July 2019 to December 2019:

Study Name: Concussion Assessment, Research and Education (CARE) Consortium

Issue: Some participants’ data are currently being removed from the FITBIR Repository. At this moment, all datasets for CARE have been put into the Private Status and are inaccessible to FITBIR Data Access Users. Please refrain from using the data that were downloaded from July 2019 to December 2019.  The updated datasets will be shared once the CARE team has completed their upload of the corrected data.

For additional inquiries of the CARE data, please reach out to the CARE Helpdesk by email: carefitb@iupui.edu.

Apologies for the inconvenience, and thank you for your patience.


FITBIR Operations on behalf of Concussion Assessment, Research, and Education (CARE) Consortium.


Come visit us at the 2019 Military Health System Research Symposium (MHSRS). This is the Department of Defense’s premier scientific meeting. FITBIR will have a booth at the symposium Monday, August 19th- Wednesday, August 21st. Come by to ask questions, get a demo of the system, or to just say hello.


Federal Interagency Traumatic Brain Injury Research Analysis Award Announcement

Opportunity Number: W81XWH-19-PHTBIRP-FITBIRA

Intent: Proposed research must analyze existing FITBIR data. Funding from the FITBIR Analysis Award will not support animal research or prospective (active) enrollment of human subjects. Applications may supplement FITBIR data with other public or private data sources.


• Pre-Application Submission Deadline: 5:00 p.m. Eastern time (ET), August 7, 2019

• Application Submission Deadline: 11:59 p.m. ET, September 5, 2019

• End of Application Verification Period: 5:00 p.m. ET, September 10, 2019

• Peer Review: November 2019

• Programmatic Review: February 2020

For information about Congressionally Directed Medical Research Program (CDMRP) Psychological Health and Traumatic Brain Injury Research Program funding opportunities, please click here

For more information about the National Institute of Neurological Disorders and Stroke (NINDS) funding opportunities, please click here



88,286,447 data points

597,474 head impacts recorded from sensors embedded in helmets

1,216 MRI scans of concussed, exposed and control participants

2,719 unique blood samples for genomic and proteomic analyses




Findings from CARE Consortium added to a global repository for brain injury data


As of August 1, 2019 there are (16) studies with ‘shared’ data available in FITBIR.  For the latest list of studies, please navigate to the Submitted Data page. Once there, scroll down to the Repository Studies table. Above the table on the left hand side, choose the 1st dropdown and select ‘All Studies with Shared Data’.  Once presented with all the studies with shared data, you can then select additional filters or search terms to further refine your selection within this cohort.


FITBIR is 21CFRPart11https://brics.cit.nih.gov/sites/default/files/styles/freeform/public/2019-01/icon-document-file-pdf.pngcertified and subsequently electronic records and electronic signatures within BRICS are considered trustworthy, reliable, and equivalent to paper records.


Please stop by our booth at the 2019 National Neurotrauma Society symposium in Pittsburgh, PA. Members from our Operations team will be there Sunday, June 30th through Tuesday, July 2nd to answer any questions you may have and can also provide demos of system capabilities. Hope to see you there.


(7/6/2017) Both the DoD and NIH strongly recommend CDE compliance for all clinical TBI studies, particularly those with a FITBIR data submission requirement.  Moreover, it is highly recommended that investigators align their non-outcome measures with existing non-outcome CDE forms that have been developed and are available at the NINDS CDE website or through FITBIR.  For any grant with a FITBIR data submission requirement, non-compliance with NINDS CDEs will require programmatic approval. Studies investigating outcomes outside of the TBI CDEs should use NINDS CDEs found in other disease areas or through searching the FITBIR Data Dictionary that has over 400 standardized forms available.  As with non-CDE usage, incorporating non-TBI CDEs requires prior Programmatic approval.



Dr. Mona Hicks and COL Dallas Hack recognized for their outstanding leadership to the development of the FITBIR Informatics System at FITBIR's 2nd Stakeholders Meeting in April 2015. NINDS Director Walter Koroshetz, MD presented the awards.

The Biomedical Research Informatics Computing System (BRICS), the platform used to support the FITBIR Informatics System, won the Best Overall Federal Health IT Award at the 2015 Digital Health Xchange & Innovation Event held in Washington, DC on March 4, 2015.

On July 15, 2015, NIH's Center for Technology awarded the 2015 Scientific Award of Merit for the development of the Biomedical Research Informatics Computing System (BRICS) to accelerate biomedical discovery through data sharing.

On August 7, 2015, it was announced that BRICS was selected as one of ten finalists, out of 130 nominations, for the 2015 GCN Award for Outstanding Information Technology Advancement in Government award. The awards ceremony will be held on October 14, 2015.

TBI Investigators funded by the National Institute of Health (NIH) and The Department of Defense (DOD) have contributed over 200,000 patient clinical records from over 4500 patients to the FITBIR Informatics System. Over fifteen funded researchers have contributed as of July 1, 2015.

RFA-HD-16-001 - Secondary Analysis of Existing Database in Traumatic Brain Injury to Explore Outcomes Relevant to Medical Rehabilitation (R21) announced; application due date is October 31, 2015. Announcement




The Query Tool has been redesigned with a sleek and elegant interface and improved         performance. New features include helpful tips about Query Tool functionality, and a clear display for searching and viewing the data results. Additionally, users will be able to lock columns, adjust column width and retract filter panes for maximized data table size. 


Users are now able to view their registered PseudoGUIDs in the My GUIDs Section of the GUID Module. The system has linked the PseudoGUIDs to the converted GUIDs so users can keep track of their unique identifiers for each subject.


Upgrades to the system have increased the speed of the user interface, and improved performance of data upload and download. Network enhancements will maximize user experience and user workflow within the system.





eForms are now accessible and can be viewed by all users in the Data Dictionary. Users will be able to add eForms when using ProFoRMS to manage protocols to electronically collect data.


A schema mapping file is now part of the data elements reports of a Form Structure. The schema mapping file maps FITBIR’s Permissible Values to other systems’ data collecting standards for metadata such as the Clinical Data Interchange Standards Consortium (CDISC).


TBI NINDS Recommended Standard Data Collection Forms Now Available for Use: 421 TBI NINDS Standard recommended data collection forms are now ready to be used by the FITBIR User Community. This list can be viewed in the TBI Forms page.

Sports Related Concussion Common Data Element (CDE) Working Group: FITBIR has been working with the Sports-Related Concussion Common Data Element (CDE) Working Group classifying case report forms for sports-related concussions as they pertain to different timeframes in a subject’s injury history. FITBIR has been assisting in this process by providing current TBI unique data elements that have already been curated, which will be reviewed and converted for sports-related concussions CDEs.

FITBIR would like to welcome the following prospective studies:


The following is a complete list of FITBIR Studies that have shared datasets available for download:

  1. The Center for Neurological and Regenerative Medicine (CNRM) own Diane Damiano , MD has successfully submitted data for her study Effects of Rapid-Resisted Exercise on Ambulatory Adults with Traumatic Brain Injury. The shared data includes 46 subjects who participated in the clinical trial that assessed the effects of exercise on brain function on ambulatory individuals with TBI.
  2. The National Institutes of Health Clinical Center (NIHCC) Leighton Chan, Ph. D has successful submitted data for his study Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients with TBI. The shared data includes 12 subjects and 9 data collection forms.
  3. The Uniformed Services University of Health Sciences (USUHS) own Michael Roy, MD, MPH, has successfully submitted data for his study Predictors of PTSD and Post Concussive Syndrome in OIF/OEF Veterans. The shared data includes 85 subjects and 18 data collection forms.
  4. Corinna E Lathan, Ph.D., from AnthroTronix, Inc, has successfully submitted data for her study An Independent, Prospective, Head-to-Head Study of the Reliability and Validity of Neurocognitive Test Batteries for the Assessment of Mild Traumatic Brain Injury. The shared data includes 233 subjects and 13 data collection forms.
  5. George Manley, MD, Ph. D, from the University of California, San Francisco, has successfully submitted data for his pilot study, Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot. The shared data includes 599 subjects and 26 data collection forms.
  6. Emory University’s David Wright, MD and his collaborators at the Medical University of South Carolina (MUSC) for successfully and completely submitting legacy data from the Progesterone for Traumatic Brain Injury, Experimental Clinical Treatment (PROTECT III) trial to FITBIR. A special thanks to Cassidy Connor, MS and Yuko Palesch, Ph. D from MUSC for all of their support. The shared data includes 882 subjects and 39 data collection forms.
  7. The University of Maryland TBI researchers, Rao Gullapalli, MD and Chandler Sours, PhD for successfully and completely submitting data for the retrospective study, as well as, the prospective study for Maryland Magnetic Resonance Imaging of Neurotrauma Study (MagNeTS) to FITBIR. The shared data includes 332 subjects and 28 data collection forms.
  8. Boston University’s Anne McKee, MD and Lauren Murphy for successfully and completely submitting the Chronic Traumatic Encephalopathy (CTE) Consensus Slides images in FITBIR for their study Tauopathy Consensus Study of Pathology Images. These slides were discussed in the 2016 article in the Acta Neuropathologica Journal. The images are in a format that can be viewed using the freeware Aperio's ImageScope software. The shared data includes 25 subjects and the Imaging Digital Pathology data collection form.
  9. The University of Washington TBI researcher, Frederick Rivara, MD, successfully and completely submitted legacy data for the study Disability Form Pediatric Traumatic Brain Injury as part of the Child Health After Injury (CHAI) Study. The shared data includes to FITBIR 927 subjects and 49 data collection forms.
  10. Harvard Medical School and RTI International with Principal Investigators Ross Zafonte, DO and Helen Pan, PhD for successfully and completely submitting legacy data from the Citicoline Brain Injury Treatment Trial (COBRIT) to FITBIR. The shared data includes 1213 subjects and 56 data collection forms.



July 9-12th
FITBIR will have a booth at the NNS 2017 conference. Our staff will be available to answer questions and for 1-on-1 sessions.