BRRC Weekly Meeting Purpose 1. Cultivate our community 2. Share our science 3. Real time...
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Transcript of BRRC Weekly Meeting Purpose 1. Cultivate our community 2. Share our science 3. Real time...
BRRC Weekly MeetingBRRC Weekly Meeting
PurposePurpose1.1. Cultivate our communityCultivate our community2.2. Share our scienceShare our science3.3. Real time communicationsReal time communications
BRRC weekly meeting BRRC weekly meeting specsspecs
• Each Monday from after Labor Day Each Monday from after Labor Day until last Monday before Memorial until last Monday before Memorial Day (except federal holidays) Day (except federal holidays)
• 4:30-5:304:30-5:30• VA-UF Education Building VA-UF Education Building
conference roomconference room
BRRC weekly meeting BRRC weekly meeting agendaagenda
• 4:30-4:454:30-4:45 AnnouncementsAnnouncements• 4:45-5:154:45-5:15 Scientific talkScientific talk• 5:15-5:30 5:15-5:30 Question/AnswerQuestion/Answer
Everyone is expected to:Everyone is expected to:• AttendAttend• Actively listen and contribute to Actively listen and contribute to
discussionsdiscussions• Willingly present once per yearWillingly present once per year
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
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...to bind up the nation’s wounds; to care for him who shall have borne the battle...
...Abraham Lincoln, March 4, 1865...Abraham Lincoln, March 4, 1865
BRRC reviewed
•BRRC-• Purpose =
•About veterans-age related disease and war related injuries to the nervous system
•NEUROrehabilitation innovation and evolution
CORES
TREATMENTINITIATIVES
BRRC: NEUROrehabilitation innovation and evolution
2009to
2014
2004to
2009
1999to
2004MOTOR
COGNITIVE
FUNC
IMAGING
HUMAN
MTR
PERF
Rehabilitation Neuroscience
ResearchINITIATIVE
Our overarching question is how can CNS (brain Our overarching question is how can CNS (brain and spinal cord) structure and function be driven and spinal cord) structure and function be driven
to remodel in the months and years after to remodel in the months and years after damage?damage?
• There is overwhelming evidence to indicate that CNS continuously There is overwhelming evidence to indicate that CNS continuously remodels its neural circuitry across our lifespan in order to encode remodels its neural circuitry across our lifespan in order to encode new experiences (Black et al., 1997; Grossman et al., 2002) and new experiences (Black et al., 1997; Grossman et al., 2002) and our goal is to capitalize upon the way the brain normally learns.our goal is to capitalize upon the way the brain normally learns.
• We believe the endogenous process of functionally appropriate We believe the endogenous process of functionally appropriate
reorganization in healthy brains and spinal cords is key to reorganization in healthy brains and spinal cords is key to promoting reorganization of remaining tissue in the damaged promoting reorganization of remaining tissue in the damaged mature CNS.mature CNS.
• This approach of using learning, alone and in combination with This approach of using learning, alone and in combination with other therapies, to promote adaptive neural plasticity is a growing other therapies, to promote adaptive neural plasticity is a growing focus of research in animal models of CNS damage (Jones et al., focus of research in animal models of CNS damage (Jones et al., 1998; Johansson, 2000; 2003; Jones et al., 2003; Monfils et al., 1998; Johansson, 2000; 2003; Jones et al., 2003; Monfils et al., 2005) and forms the basis of our approach to human 2005) and forms the basis of our approach to human neurorehabilitation clinical trials. neurorehabilitation clinical trials.
BRRC reviewed•Problem = neurorehabilitation lags behind other biomedical discovery•History of nihilism about neurorehablitation
Are functional deficits treatable?Are functional deficits treatable?
Our Professional NihilismOur Professional Nihilism
Consolidation of nihilism about Consolidation of nihilism about the potential of the potential of
neurorehabilitationneurorehabilitation Santiago Ramon y CajalSantiago 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
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
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
““The popular belief that only The popular belief that only randomized, controlled trials produce randomized, controlled trials produce trustworthy results and that all trustworthy results and that all observational studies are misleading observational studies are misleading does a disservice to … clinical does a disservice to … clinical investigation….” (Concato et al, 2000)investigation….” (Concato et al, 2000)
““A major fault with evidence-based A major fault with evidence-based medicine is its emphasis on medicine is its emphasis on randomized controlled trials” (Iggo, randomized controlled trials” (Iggo, 1995).1995).
Rehabilitation and Neural Repair:The Maturation of Treatments
from Discovery at the Bench to Changing Care for AllConceptConcept ApplicationApplicationInnovationInnovation EvolutionEvolution
Basic scienceBasic science Phase 1 Clinical Trial Phase 1 Clinical Trial Phase 2 Clinical Phase 2 Clinical TrialTrial
Phase 3 Clinical TrialPhase 3 Clinical Trial Health Services Health Services ResearchResearch
Rehabilitation and Neural Repair:The Maturation of Treatments
from Discovery at the Bench to Changing Care for AllConceptConcept ApplicationApplicationInnovationInnovation EvolutionEvolution
Clinical trials: a process of Clinical trials: a process of evolutionevolution
• Each phase asks an important but Each phase asks an important but different questiondifferent question
• Each phase may involve revision of the Each phase may involve revision of the treatment method based upon what was treatment method based upon what was learnedlearned
• Each subsequent phase is reliant on Each subsequent phase is reliant on successful resolution and completion of successful resolution and completion of the prior phase question.the prior phase question.
Basic science Translational rehabilitation neuroscience
research
Exploratory Clinical Study
Phase 1 Clinical Trial
Phase 2 Clinical Trial
Phase 3 Clinical Trial
Health Services Research
Purpose Basic Discovery Translation 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 AllConceptConcept ApplicationApplicationInnovationInnovation EvolutionEvolution
Clinical trials: a process of Clinical trials: a process of evolutionevolution
• Each phase asks an important but different Each phase asks an important but different questionquestion
• Each phase may involve revision of the Each phase may involve revision of the treatment method based upon what was treatment method based upon what was learnedlearned
• Each subsequent phase is reliant on successful Each subsequent phase is reliant on successful resolution and completion of the prior phase resolution and completion of the prior phase question.question.
• Each phase requires rigorous but different Each phase requires rigorous but different scientific methods using sophisticated scientific methods using sophisticated experimental designs specifically tailored experimental designs specifically tailored to answer the specific questions askedto answer the specific questions asked
Basic science Translational rehabilitation neuroscience
research
Exploratory Clinical Study
Phase 1 Clinical Trial
Phase 2 Clinical Trial
Phase 3 Clinical Trial
Health Services Research
Purpose Basic Discovery Translation from animal to human application; normal human to pathology
Treatment Innovation
Treatment Evolution/Formalization
Treatment Efficacy
Treatment Effectiveness
Delivery Method/Societal Impact
ParticipantModel
Animal or human
Animal to human, normal to pathology
Human individuals
Replications of individuals
Human groupings
Human populations
Populations and Institutions
Research Methodology
Within subject and group comparisons
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 AllConceptConcept ApplicationApplicationInnovationInnovation EvolutionEvolution
Clinical trials: a process of Clinical trials: a process of evolutionevolution
• Each phase asks an important but different questionEach phase asks an important but different question• Each phase may involve revision of the treatment Each phase may involve revision of the treatment
method based upon what was learnedmethod based upon what was learned• Each subsequent phase is reliant on successful Each subsequent phase is reliant on successful
resolution and completion of the prior phase resolution and completion of the prior phase question.question.
• Each phase requires rigorous but different scientific Each phase requires rigorous but different scientific methods using sophisticated experimental designs methods using sophisticated experimental designs specifically tailored to answer the specific specifically tailored to answer the specific questions askedquestions asked
• Because the questions asked vary across phases, Because the questions asked vary across phases, outcome measures should differ by phase.outcome measures should differ by phase.
Basic science Translational rehabilitation neuroscience
research
Exploratory Clinical Study
Phase 1 Clinical Trial
Phase 2 Clinical Trial
Phase 3 Clinical Trial
Health Services Research
Purpose Basic Discovery Translation from animal to human application; normal human to pathology
Treatment Innovation
Treatment Evolution/Formalization
Treatment Efficacy
Treatment Effectiveness
Delivery Method/Societal Impact
ParticipantModel
Animal or human
Animal to human, normal to pathology
Human individuals
Replications of individuals
Human groupings
Human populations
Populations and Institutions
Research Methodology
Within subject and group comparisons
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 basedQuantification of TX effect
Individual, tx specific probe, performance basedQuantification of TX effect
Individual, tx specific probe, performance basedQuantification of TX effect
Individual, tx specific probe, performance basedQuantification of TX effect
Individual, tx specific probe, performance basedQuantification 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 AllConceptConcept ApplicationApplicationInnovationInnovation EvolutionEvolution
Basic science Translational
rehabilitation
neuroscience research
Exploratory Clinical Study
Phase 1 Clinical Trial
Phase 2 Clinical Trial
Phase 3 Clinical Trial
Health Services Research
Purpose Basic Discovery Translation from animal to human application; normal human to pathology
Treatment Innovation
Treatment Evolution/Formalization
Treatment Efficacy
Treatment Effectiveness
Delivery Method/Societal Impact
Barriers Questions not guided by the human experience; complain that the clinical perspective is impenetrable
Few researchers 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 trials
ConceptConcept ApplicationApplicationInnovationInnovation EvolutionEvolution
Clinical trials: a process of Clinical trials: a process of evolutionevolution
• Each phase asks an important but different questionEach phase asks an important but different question• Each phase may involve revision of the treatment Each phase may involve revision of the treatment
method based upon what was learnedmethod based upon what was learned• Each subsequent phase is reliant on successful Each subsequent phase is reliant on successful
resolution and completion of the prior phase resolution and completion of the prior phase question.question.
• Each phase requires rigorous but different scientific Each phase requires rigorous but different scientific methods using sophisticated experimental designs methods using sophisticated experimental designs specifically tailored to answer the specific specifically tailored to answer the specific questions askedquestions asked
• Because the questions asked vary across phases, Because the questions asked vary across phases, outcome measures should differ by phase.outcome measures should differ by phase.
Basic science Translational research
Exploratory Clinical Study
Phase 1 Clinical Trial
Phase 2 Clinical Trial
Phase 3 Clinical Trial
Health Services Research
Purpose Basic Discovery
Translation from animal to human application; normal human to pathology
Treatment Innovation
Treatment Evolution/Formalization
Treatment Efficacy
Treatment Effectiveness
Delivery Method/Societal Impact
ParticipantModel
Animal or human
Animal to human, normal to pathology
Human individuals
Replications of individuals
Human groupings
Human populations
Populations and Institutions
Research Methodology
Within subject and group comparisons
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 basedQuantification of TX effect
Individual, tx specific probe, performance basedQuantification of TX effect
Individual, tx specific probe, performance basedQuantification of TX effect
Individual, tx specific probe, performance basedQuantification of TX effect
Individual, tx specific probe, performance basedQuantification 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, 21:194-197
ConceptConcept ApplicationApplicationInnovationInnovation EvolutionEvolution
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