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Introduction¹

Millions of Americans experience a traumatic brain injury (TBI) each year, often with lengthy and debilitating effects on these patients and their families (NASEM, 2022). Despite being a leading cause of morbidity and mortality in the United States, substantial unmet needs persist in the areas of TBI prevention, treatment, and recovery. In response to these challenges, the development of new tools and approaches is underway—particularly for TBI diagnostics and symptom management. A recent swell of research and development (R&D) activity across academia and industry reflects growing interest in these domains. This workshop was convened to highlight examples of TBI innovation, explore areas of recent research and technical progress, examine potential near-term and midterm opportunities, and highlight challenges for clinical R&D development and real-world implementation. A handful of technologies or products discussed by speakers served as selected examples of innovation in the field. Workshop examples from diagnostic biomarker development, injury prevention in professional sports, vehicle collisions, machine learning tools, clinical trial design, neuromodulation, and pharmacological treatment were selected to reflect a non-comprehensive cross-section of active innovation domains to drive dialogue about emergent findings, research trends, and promising

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¹ The planning committee’s role was limited to planning the workshop, and this Proceedings of a Workshop has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.

opportunities. Though TBIs span a range of severities, from concussion to coma, workshop presentations and discussions primarily focused on TBIs at the milder end of the severity spectrum (e.g., those not requiring lengthy hospitalization), which represent the majority of TBI incidences. With a recent National Academies of Sciences, Engineering, and Medicine (the National Academies) activity having explored biomarkers for TBI diagnosis and assessment (NASEM, 2023), opening sessions of this workshop connected to this prior work by discussing how recent progress in diagnostics using blood-based biomarkers illustrate challenges and opportunities in the translation of innovation. In subsequent sessions, the focus shifted to other innovation domains, including TBI prevention and symptom management.

In opening comments, Corinne Peek-Asa, vice chancellor for research at University of California San Diego, highlighted that the Forum on Traumatic Brain Injury was established in response to a report commissioned by the National Academies of Sciences, Engineering, and Medicine, Traumatic Brain Injury: A Roadmap for Accelerating Progress (NASEM, 2022). Peek-Asa noted that this workshop, the fourth public convening of this new forum, is the continuation of a series intended to accelerate progress in TBI by addressing critical knowledge gaps in research and care systems, with special attention given to the needs of TBI survivors and their families.

Christina L. Master, pediatrician and sports medicine specialist at Children’s Hospital of Philadelphia and professor at the University of Pennsylvania, emphasized the representation of diverse disciplines and sectors attending the workshop and the value of collaborative relationships in moving the TBI field forward. The workshop also brought implementation² (e.g., integration of an evidence-based intervention in a clinical setting) to the forefront, she said, by featuring it as the focus of the first topical session, highlighting the importance of acknowledging the facilitators and barriers of real-world change in conversations about research and health care innovation. Master also underscored the workshop’s big-picture goal of considering how innovation can support improved patient outcomes. TBI patient and caregiver lived experiences were woven throughout the sessions to give voice to their priorities and perspectives. Master emphasized that the workshop planning committee’s aim in selecting speakers was to

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² In the context of health technology, implementation describes the process of integrating evidence-based practices. Interventions and policies are effectively translated to and used in real-world health care delivery settings. See also the National Institutes of Health Office of Disease Prevention website at https://prevention.nih.gov/research-priorities/dissemination-implementation (accessed September 16, 2024). Areas of implementation can include approaches that strive to address barriers to adoption, mitigate health disparity, promote best practices, coordinate efforts across different sectors of the health system (clinical, administrative, community stakeholders, payors, etc.), and monitor for impact, efficacy, and sustainability, among others.

provide useful and instructive case examples. Their inclusion in the workshop should not be construed as an endorsement of any device, modality, or company, in accordance with the policies of the National Academies of Sciences, Engineering, and Medicine.

WORKSHOP OBJECTIVES

To explore examples of innovative technologies targeted at TBI prevention, treatment, and recovery management, the Forum on Traumatic Brain Injury hosted a 1-day public workshop on April 15, 2024, titled Innovation Trends in Technologies for the Prevention, Treatment, and Management of Traumatic Brain Injury, to better understand, at a broader level, significant unaddressed needs, areas of recent research and technical progress, near-term and midterm opportunities, and challenges driving breakthrough research and development areas in TBI. Invited presentations and discussions were designed to do the following:

• Explore potential mechanisms for addressing major unmet needs in TBI prevention, treatment, and management through technological innovation, with consideration to patient, family, and provider priorities.
• Consider how ongoing scientific and technical advances yield promising innovation opportunities for some aspects of TBI prevention, treatment, and management, while others remain underdeveloped.
• Consider how implementation needs should be incorporated into the research and development process.
• Identify critical knowledge gaps where technology is needed to transform care, particularly in regard to assessing whether, when, and how prevention, treatment, and management approaches improve outcomes over time, and for which patients.

ORGANIZATION OF THE PROCEEDINGS OF THE WORKSHOP

This proceedings summarizes the presentations and discussions from the workshop Innovation Trends in Technologies for the Prevention, Treatment, and Management of Traumatic Brain Injury. Chapter 1 introduces the workshop’s task and focus on innovation. Chapter 2 explores implementation considerations in developing and implementing innovations addressing TBI, including elements involved in changing practices and processes. The chapter provides reflections on the use of blood biomarkers to assist in diagnosing mild TBI, uses this example to highlight the integration of patient engagement in all stages of health technology development and implementation, reviews expert feedback on the implementation of

TBI assessment tools in the military, and outlines public and private payer considerations for new technologies. Chapter 3 focuses on innovations to aid in TBI prevention and opens with a firsthand account of sustaining and recovering from TBI. The chapter examines three major causes of TBI—sports injuries, motor vehicle crashes, and falls for older adults—reviews examples of research efforts in these areas, and describes the potential for personalized prevention technology.

Chapter 4 examines clinical decision support technologies and opens with a patient account of the difficulty in obtaining TBI diagnosis and treatment. Speakers discuss innovations such as machine learning approaches, ultrahigh-performance imaging, electrophysiological biomarkers, and eye-tracking devices. Chapter 5 highlights innovations in TBI treatment. The chapter opens with a firsthand account of a father contending with the long-term effects of chronic TBI on his daughter decades after her injury. The chapter then outlines innovative clinical trial designs to increase learning efficiency and features various pharmacological and nonpharmacological treatment advances. Chapter 6 contains reflections on the sessions, offered by the workshop cochair. Appendix A contains the reference list. See Appendixes B and C for the workshop statement of task and agenda and Appendix D for brief biographies of speakers, moderators, and planning committee members.