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Summary . Methodological Issues in Traumatic Brain Injury. Mark Lovell – civilian population. Athletes provide unique setting to study TBI Baseline, pre-injury assessments possible in population that has high likelihood of injury. Allows for longitudinal studies in mild TBI

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Summary

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  1. Summary Methodological Issues in Traumatic Brain Injury

  2. Mark Lovell – civilian population • Athletes provide unique setting to study TBI • Baseline, pre-injury assessments possible in population that has high likelihood of injury. • Allows for longitudinal studies in mild TBI • Repetitive injury, female gender and younger age associated with poorer outcome • 3 or more prior injuries more likely to have on-field clinical markers of injury • High school athletes prolonged recovery compared to college • In sports played by both sexes, female higher rate of mTBI

  3. Mark Lovell – civilian population • Management of injury/ Importance of neuropsychological assessment and clinical evaluation • Pressures to return to competition • Ensure patient return to baseline levels and asymptomatic prior to return to play

  4. Michael Jaffee – military population (acute) • High frequency of TBI in returning soldiers and veterans • OIF/OEF - improvements in body armor, combat lifesaving techniques, and increases in survivability • Life-threatening consequences due to TBI impairments • Development of in-theater mTBI detection instruments • Military Acute Concussion Evaluation (MACE) • ANAM4 in-theater TBI battery

  5. Michael Jaffee – military population (acute) • Methodological issues of in-theater studies of TBI • Extremely dangerous environment • Logistics - study sites, IRB requirements for overseas military operations • Potential confounders in assessment and studies, due to nature of service • Sleep deprivation • Hyper-arousal • Psychiatric comorbidities • Other injuries • Motivation, commitment, return to mission and unit

  6. Karen Schwab – military population (chronic) • Difficulties in identifying population with chronic mild TBI • Large population of “undiagnosed” • Inadequacy of diagnostic codification • Return from deployment – large number remain symptomatic • Development of post-deployment screening tools for TBI • Psychological/psychiatric consequences after TBI • Depression, PTSD, others

  7. Karen Schwab – military population (chronic) • Methodological difficulties in treatment trials for chronic TBI • Resource intensive, lengthy, IRB approvals, sponsorship for non-pharmaceutical treatments, blinding/randomization issues • Recruitment difficulties for clinical trials • Multiple deployments, comorbid conditions, issue of concomitant medications post-mission or injury • Limited Class 1 evidence for TBI pharmacotherapy or treatment • Great need for future trials of pharmaceutical management, rehabilitation, and prevention

  8. Douglas Smith - Mechanisms of TBI • Translatability of animal to human models and vice-versa • Diffuse Axonal Injury – “the most important and most common patholody of TBI” • Difficult to detect/model • Molecules to Man - sophisticated gyrencephalic model of mTBI via rotational acceleration in pig more accurate animal model to explore pharmacotherapy and MOA

  9. Ross Bullock • Although successful pre-clinical and phase 1 -2 trials suggestive of efficacy, why such high failure rates? • Numerous promising compounds terminated or failed after large investments of time and money • Sophisticated understanding of compound, patients, PK/PD, POM needed to increase success • Differences in patient populations, methodology confound studies • Development of “STAIR”-like criteria for TBI trials

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