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BRRC Weekly Meeting Purpose 1. Cultivate our community 2. Share our science 3. Real time communications.

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Presentation on theme: "BRRC Weekly Meeting Purpose 1. Cultivate our community 2. Share our science 3. Real time communications."— Presentation transcript:

1 BRRC Weekly Meeting Purpose 1. Cultivate our community 2. Share our science 3. Real time communications

2 BRRC weekly meeting specs Each Monday from after Labor Day until last Monday before Memorial Day (except federal holidays) Each Monday from after Labor Day until last Monday before Memorial Day (except federal holidays) 4:30-5:30 4:30-5:30 VA-UF Education Building conference room VA-UF Education Building conference room

3 BRRC weekly meeting agenda 4:30-4:45Announcements 4:30-4:45Announcements 4:45-5:15Scientific talk 4:45-5:15Scientific talk 5:15-5:30 Question/Answer 5:15-5:30 Question/Answer Everyone is expected to: Attend Attend Actively listen and contribute to discussions Actively listen and contribute to discussions Willingly present once per year Willingly present once per year

4 BRRC reviewed Purpose = About veterans-age related disease and war related injuries to the nervous system NEUROrehabilitation innovation and evolution Problem = neurorehabilitation lags behind other biomedical discovery History of nihilism about neurorehablitation Particularly difficult research to do Unique difficulties to participating in rehabilitation research Dearth of adequate outcome measures for appropriately measuring the impact of various forms of neurorehabilitation Limited appreciation for clinical trials methodology Focus The neuroscience of learning, injury and recovery Use dependent learning-a paradigm shift for neuro rehabilitation

5 BRRC Purpose = About veterans-age related disease and war related injuries to the nervous system... to bind up the nation’s wounds; to care for him who shall have borne the battle......Abraham Lincoln, March 4, 1865

6 BRRC reviewed BRRC- Purpose = About veterans-age related disease and war related injuries to the nervous system NEUROrehabilitation innovation and evolution

7 CORES TREATMENT INITIATIVES BRRC: NEUROrehabilitation innovation and evolution 2009 to to to 2004 MOTORMOTOR COGNITIVECOGNITIVE FUNCIMAGINGFUNCIMAGING HUMAN MTRPERFHUMAN MTRPERF Rehabilitation Neuroscience Research INITIATIVE

8 Our overarching question is how can CNS (brain and spinal cord) structure and function be driven to remodel in the months and years after damage? There is overwhelming evidence to indicate that CNS continuously remodels its neural circuitry across our lifespan in order to encode new experiences (Black et al., 1997; Grossman et al., 2002) and our goal is to capitalize upon the way the brain normally learns. There is overwhelming evidence to indicate that CNS continuously remodels its neural circuitry across our lifespan in order to encode new experiences (Black et al., 1997; Grossman et al., 2002) and our goal is to capitalize upon the way the brain normally learns. We believe the endogenous process of functionally appropriate reorganization in healthy brains and spinal cords is key to promoting reorganization of remaining tissue in the damaged mature CNS. We believe the endogenous process of functionally appropriate reorganization in healthy brains and spinal cords is key to promoting reorganization of remaining tissue in the damaged mature CNS. This approach of using learning, alone and in combination with other therapies, to promote adaptive neural plasticity is a growing focus of research in animal models of CNS damage (Jones et al., 1998; Johansson, 2000; 2003; Jones et al., 2003; Monfils et al., 2005) and forms the basis of our approach to human neurorehabilitation clinical trials. This approach of using learning, alone and in combination with other therapies, to promote adaptive neural plasticity is a growing focus of research in animal models of CNS damage (Jones et al., 1998; Johansson, 2000; 2003; Jones et al., 2003; Monfils et al., 2005) and forms the basis of our approach to human neurorehabilitation clinical trials.

9 BRRC reviewed Problem = neurorehabilitation lags behind other biomedical discovery History of nihilism about neurorehablitation

10 Are functional deficits treatable? Our Professional Nihilism

11 Finger, 1994, p.15 Aristotle ( B.C.)

12 Consolidation of nihilism about the potential of neurorehabilitation Santiago Ramon y Cajal “Once development was ended, the founts of growth and regeneration of axons and dendrites dried up irrevocably. In adult centres, the nerve paths are something fixed and immutable; everything may die, nothing may be regenerated” (p.750) Finger, 1994, p47

13 BRRC reviewed BRRC- Purpose = About veterans-age related disease and war related injuries to the nervous system NEUROrehabilitation innovation and evolution Problem = neurorehabilitation lags behind other biomedical discovery History of nihilism about neurorehablitation Particularly difficult research to do Unique difficulties to participating in rehabilitation research - length of participation - exquisite selection criteria Dearth of adequate outcome measures for appropriately measuring the impact of various forms of neurorehabilitation

14 BRRC reviewed BRRC- Purpose = About veterans-age related disease and war related injuries to the nervous system NEUROrehabilitation innovation and evolution Problem = neurorehabilitation lags behind other biomedical discovery History of nihilism about neurorehablitation Particularly difficult research to do Unique difficulties to participating in rehabilitation research Dearth of adequate outcome measures for appropriately measuring the impact of various forms of neurorehabilitation Limited appreciation for clinical trials methodology; Phases Translations Maturation

15 “The popular belief that only randomized, controlled trials produce trustworthy results and that all observational studies are misleading does a disservice to … clinical investigation….” (Concato et al, 2000) “A major fault with evidence-based medicine is its emphasis on randomized controlled trials” (Iggo, 1995).

16 Rehabilitation and Neural Repair: The Maturation of Treatments from Discovery at the Bench to Changing Care for AllConceptApplicationInnovationEvolution

17 Basic science Phase 1 Clinical Trial Phase 2 Clinical Trial Phase 3 Clinical Trial Health Services Research Rehabilitation and Neural Repair: The Maturation of Treatments from Discovery at the Bench to Changing Care for AllConceptApplicationInnovationEvolution

18 Clinical trials: a process of evolution Each phase asks an important but different question Each phase asks an important but different question Each phase may involve revision of the treatment method based upon what was learned Each phase may involve revision of the treatment method based upon what was learned Each subsequent phase is reliant on successful resolution and completion of the prior phase question. Each subsequent phase is reliant on successful resolution and completion of the prior phase question.

19 Basic scienceTranslational rehabilitation neuroscience research Exploratory Clinical Study Phase 1 Clinical Trial Phase 2 Clinical Trial Phase 3 Clinical Trial Health Services Research Purpose Basic DiscoveryTranslation from animal to human application; normal human to pathology Treatment Innovation Treatment Evolution/ Formalization Treatment Efficacy Treatment Effectiveness Delivery Method/ Societal Impact Rehabilitation and Neural Repair: The Maturation of Treatments from Discovery at the Bench to Changing Care for AllConceptApplicationInnovationEvolution

20 Clinical trials: a process of evolution Each phase asks an important but different question Each phase asks an important but different question Each phase may involve revision of the treatment method based upon what was learned Each phase may involve revision of the treatment method based upon what was learned Each subsequent phase is reliant on successful resolution and completion of the prior phase question. Each subsequent phase is reliant on successful resolution and completion of the prior phase question. Each phase requires rigorous but different scientific methods using sophisticated experimental designs specifically tailored to answer the specific questions asked Each phase requires rigorous but different scientific methods using sophisticated experimental designs specifically tailored to answer the specific questions asked

21 Basic scienceTranslational rehabilitation neuroscience research Exploratory Clinical Study Phase 1 Clinical Trial Phase 2 Clinical Trial Phase 3 Clinical Trial Health Services Research Purpose Basic DiscoveryTranslation from animal to human application; normal human to pathology Treatment Innovation Treatment Evolution/ Formalization Treatment Efficacy Treatment Effectiveness Delivery Method/ Societal Impact Participant Model Animal or humanAnimal to human, normal to pathology Human individuals Replications of individuals Human groupings Human populationsPopulations and Institutions Research Methodolog y Within subject and group comparisons Individual, small group. Within subject experimental designs Small N Group. Within subject experimental designs, repeated across subjects Medium N Group. Randomized group designs Large N Group, population. Multisite randomized clinical trial Large group, population, institutional system. Group designs Rehabilitation and Neural Repair: The Maturation of Treatments from Discovery at the Bench to Changing Care for AllConceptApplicationInnovationEvolution

22 Clinical trials: a process of evolution Each phase asks an important but different question Each phase asks an important but different question Each phase may involve revision of the treatment method based upon what was learned Each phase may involve revision of the treatment method based upon what was learned Each subsequent phase is reliant on successful resolution and completion of the prior phase question. Each subsequent phase is reliant on successful resolution and completion of the prior phase question. Each phase requires rigorous but different scientific methods using sophisticated experimental designs specifically tailored to answer the specific questions asked Each phase requires rigorous but different scientific methods using sophisticated experimental designs specifically tailored to answer the specific questions asked Because the questions asked vary across phases, outcome measures should differ by phase. Because the questions asked vary across phases, outcome measures should differ by phase.

23 Basic scienceTranslational rehabilitation neuroscience research Exploratory Clinical Study Phase 1 Clinical Trial Phase 2 Clinical Trial Phase 3 Clinical Trial Health Services Research Purpose Basic DiscoveryTranslation from animal to human application; normal human to pathology Treatment Innovation Treatment Evolution/ Formalization Treatment Efficacy Treatment Effectiveness Delivery Method/ Societal Impact Participant Model Animal or humanAnimal to human, normal to pathology Human individuals Replications of individuals Human groupings Human populationsPopulations and Institutions Research Methodolog y Within subject and group comparisons Individual, small group. Within subject experimental designs Small N Group. Within subject experimental designs, repeated across subjects Medium N Group. Randomized group designs Large N Group, population. Multisite randomized clinical trial Large group, population, institutional system. Group designs Outcomes Individual, tx specific probe, performance based Quantification of TX effect Individual, tx specific probe, performance based Quantification of TX effect Individual, tx specific probe, performance based Quantification of TX effect Individual, tx specific probe, performance based Quantification of TX effect Individual, tx specific probe, performance based Quantification of TX effect, personal imp act Health Status and Societal impact Institutional and Societal impact Rehabilitation and Neural Repair: The Maturation of Treatments from Discovery at the Bench to Changing Care for AllConceptApplicationInnovationEvolution

24 Basic scienceTranslational rehabilitation neuroscience research Exploratory Clinical Study Phase 1 Clinical Trial Phase 2 Clinical Trial Phase 3 Clinical Trial Health Services Research Purpose Basic DiscoveryTranslation from animal to human application; normal human to pathology Treatment Innovation Treatment Evolution/ Formalization Treatment EfficacyTreatment Effectiveness Delivery Method/ Societal Impact Barriers Questions not guided by the human experience; complain that the clinical perspective is impenetrabl e Few researche rs interested in this phase. Unfunded. Un- appreciated. Not published. Considered unscientific (inappro- priately referred to as “case studies”) Published in select journals only. Considered less rigorous and unscientific (Inappro- priately referred to as “series of case studies”) Problems with identifying appropriate outcomes; fear of publishing negative results & the potential use of this data (payers) Experimentally cumbersome. Problems with identifying appropriate outcomes; fear of publishing neg results & the potential use of this data (payers) Where the rubber meets the road… vulnerable to political climates; fear of the potential use of this data (payers) Barriers Barriers to evolution of rehabilitation clinical trialsConceptApplicationInnovationEvolution

25 Clinical trials: a process of evolution Each phase asks an important but different question Each phase asks an important but different question Each phase may involve revision of the treatment method based upon what was learned Each phase may involve revision of the treatment method based upon what was learned Each subsequent phase is reliant on successful resolution and completion of the prior phase question. Each subsequent phase is reliant on successful resolution and completion of the prior phase question. Each phase requires rigorous but different scientific methods using sophisticated experimental designs specifically tailored to answer the specific questions asked Each phase requires rigorous but different scientific methods using sophisticated experimental designs specifically tailored to answer the specific questions asked Because the questions asked vary across phases, outcome measures should differ by phase. Because the questions asked vary across phases, outcome measures should differ by phase.

26 Basic scienceTranslational research Exploratory Clinical Study Phase 1 Clinical Trial Phase 2 Clinical Trial Phase 3 Clinical Trial Health Services Research Purpose Basic DiscoveryTranslation from animal to human application; normal human to pathology Treatment Innovation Treatment Evolution/ Formalization Treatment Efficacy Treatment Effectiveness Delivery Method/ Societal Impact Participant Model Animal or humanAnimal to human, normal to pathology Human individuals Replications of individuals Human groupings Human populationsPopulations and Institutions Research Methodology Within subject and group comparisons Individual, small group. Within subject experimental designs Small N Group. Within subject experimental designs, repeated across subjects Medium N Group. Randomized group designs Large N Group, population. Multisite randomized clinical trial Large group, population, institutional system. Group designs Outcomes Individual, tx specific probe, performance based Quantification of TX effect Individual, tx specific probe, performance based Quantification of TX effect Individual, tx specific probe, performance based Quantification of TX effect Individual, tx specific probe, performance based Quantification of TX effect Individual, tx specific probe, performance based Quantification of TX effect, personal imp act Health Status and Societal impact Institutional and Societal impact Barriers Questions not guided by the human experience; complain that the clinical perspective is impenetrable Few researchers interested in this phase. Unfunded. Unappreciated. Not published. Considered unscientific (ex inappropriately referred to as “case studies”) Published in select journals only. Considered less rigorous and unscientific (ex. Inappropriately referred to as “series of case studies”) Problems with identifying appropriate outcomes; fear of publishing neg results & the potential use of this data (payers) Experimentally cumbersome. Problems with identifying appropriate outcomes; fear of publishing neg results & the potential use of this data (payers) Where the rubber meets the road…vulnerable to political climates; fear of the potential use of this data (payers) Rehabilitation and Neural Repair: The Maturation of Treatments from Discovery at the Bench to Changing Care for All Rothi, LJG. Cognitive rehabilitation: The role of theoretical rationales and respect for the maturational process needed of our evidence. J of Head Trauma Res., 2006, 21: ConceptApplicationInnovationEvolution

27 BRRC reviewed BRRC- Purpose = About veterans-age related disease and war related injuries to the nervous system NEUROrehabilitation innovation and evolution Problem = neurorehabilitation lags behind other biomedical discovery History of nihilism about neurorehablitation Particularly difficult research to do Unique difficulties to participating in rehabilitation research Dearth of adequate outcome measures for appropriately measuring the impact of various forms of neurorehabilitation Limited appreciation for clinical trials methodology; Phases Translations Maturation Focus The neuroscience of learning, injury and recovery Use dependent learning-a paradigm shift for neuro rehabilitation

28 Copyright ©2006 American Physiological Society Adkins, D. L. et al. J Appl Physiol 101: ; doi: /japplphysiol Fig. 1. Time course of molecular, anatomic, and physiological plasticity within rat motor cortex during motor skill reach training


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