Traumatic Brain Injury

In civilian, military and Veteran populations, there is an increased recognition of the interrelationship between traumatic brain injury (TBI) and some psychological health (PH) disorders, and of the need to better understand the relationships by integrating research on these topics.

The use of different measures to assess similar study variables and/or differing metrics to assess outcomes may limit important advances in PH and TBI research. Without a common set of data elements (which include variable definitions and recommended measures), comparison of findings across studies is challenging.

To develop the TBI CDE standards a variety of co-sponsoring Federal agencies led a scientific initiative to develop common data elements for TBI. 

Co-Sponsoring Federal Agencies

• National Institute of Neurological Disorders and Stroke (NINDS)
• Department of Veterans Affairs (VA)
• National Institute on Disability and Rehabilitation Research (NIDRR)
• Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury (DCOE)
• Defense and Veterans Brain Injury Center (DVBIC)

Scientific experts were invited to participate in a Working Group to develop recommendations for specific topic-driven common data elements. The resulting TBI CDE v1.0 recommendations were published on this website and in the Archives of Physical Medicine and Rehabilitation in November 2010. Additional pediatric-specific recommendations were developed and published in The Journal of Neurotrauma in March 2012.

The Federal Liaisons and Consultants for the TBI CDE Project formed four new working groups to build upon the success of the first set of recommendations (i.e., TBI CDEs Version 1.0). The goal was to expand the list of definitions to fill gaps, to update some of the recommendations based on the “beta-testing”, and to organize the CDEs in modules to make them easier to use.

The Working Group reconvened in late 2011 to refine and reorganize the CDEs according to type of TBI study around four major study types:

• Epidemiological research
• Studies on acute, hospitalized patients
• Studies of the rehabilitation for moderate/severe TBI
• Mild TBI/Concussion research

The Working Group also reduced the list of “Core” CDEs strongly recommended for NINDS-funded studies and expanded the CDEs to be more comprehensive and fill gaps. Version 2.0 of the TBI CDEs was published on this site in late June 2012 and was used to construct the Federal Interagency Traumatic Brain Injury Research informatics system, which was available for use in mid-July 2012.

The American Association of Neurological Surgeons (AANS) has stated its commitment to the NINDS TBI CDE project since the development of v1.0 and participated in the development, organization, and distribution of v2.0 of the TBI CDEs, and circulated a letter of support in 2013.

The American Congress of Rehabilitation Medicine (ACRM) also endorsed the TBI v2.0 CDEs through a letter of support.

The v2.0 CDEs are classified according to the following definitions:

• Core — small set of data elements that are relevant to all TBI clinical studies
• Basic (Supplemental for all other diseases) — small set of data elements, beyond the Core, that are recommended for inclusion in studies of Concussion/mild TBI, Acute Hospitalized, Moderate/Severe TBI: Rehabilitation, or Epidemiology
• Supplemental (Exploratory for all other diseases) — additional recommended data elements where inclusion depends upon the particulars of the study

Researchers working on acute hospitalized, concussion or mild TBI, rehabilitation of moderate or severe TBI, and epidemiology studies used these classifications as guidance to find customized sets of elements that they can incorporate into their studies.

Please note the TBI v1.0 CDE recommendations of the Demographics and Clinical Assessment Working Group are available on the IMPACT Web site. These CDE recommendations are presented using an alternate classification scheme of three levels of detail: Basic, Intermediate and Advanced, with the greatest level of detail in the Advanced version.

NINDS formed the International Traumatic Brain Injury (iTBI) Steering Committee to direct the updating and further development of Traumatic Brain Injury CDEs in 2013.

In 2017, the Biomechanical Devices in TBI CDE Working Group was convened to develop CDE recommendations. This Working Group was divided into the following subgroups: Head Accelerometry, Impact Video, Blast Exposure. The recommendations were posted in February 2018 and are part of the Disease/Injury Related Events Domain/Biomechanical Devices Subdomain on the TBI Data Standards page.

In 2025, the TBI v3.0 Working Group was convened to perform a comprehensive review and update of the TBI v2.0 and Biomechanical Devices in TBI CDEs.

The Working Group was divided into 10 domain-specific subgroups: Assessments and Examinations, Digital Technologies, General Activities of Daily Living, Neurodiagnostic Technologies: Biomarkers, Neurodiagnostic Technologies: Neuroimaging, Outcomes and Endpoints, Participant Characteristics, Performance-based Measures, Psychosocial Modifiers, Treatment/Intervention Data.

Updated Classification definitions and new Instrument Selection Criteria informed by the criteria from the PhenX Toolkit Steering Committee were used to develop the TBI v3.0 recommendations.

The Internal Review and Public Review period for the draft TBI v3.0 CDEs will take place January 12-30, 2026. The final TBI v3.0 CDE recommendations will be posted in June 2026.

Please see the Roster tab for current and previous Working Groups and the Publications tab for project-related publications.