1 / 9

Summary

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

kimn
Télécharger la présentation

Summary

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related