RFI-NOT-NS-19-060

RFI-NOT-NS-19-060

Notice Number:  NOT-NS-19-060

Key Dates:

Release Date: April 30

Response Date: July 30

Related Announcements:  None

Issued by:

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

Fogarty International Center (FIC)

Purpose

The spinal cord injury (SCI) research community has experienced great advances in discovery research, technology development, and promising clinical interventions in the past decade. To build upon these advances and maximize the benefit to persons with SCI, the NIH hosted a conference February 12-13, 2019 titled “SCI 2020: Launching a Decade of Disruption in Spinal Cord Injury Research”. The purpose of the conference was to bring together a broad range of stakeholders including researchers, clinicians and health care professionals, individuals with SCI, industry partners, regulators, and funding agency representatives to break down existing communication silos. The participants were asked to critically evaluate the state of the science, assess areas of technological and community readiness, and build collaborations that could change the trajectory of research and clinical options for people with SCI.

Six primary sessions featured brief presentations of recent scientific advances and critical research questions for the future. Facilitators and audience participation were encouraged to identify opportunities and areas for collaboration. The North American Spinal Cord Injury Consortium and other public members provided personal context of individuals living with SCI to defining future research priorities. In five final breakout sessions, stakeholders discussed and identified key gaps and priorities for SCI research in the next decade. The open sessions for both days of the conference can be viewed at https://videocast.nih.gov/summary.asp?live=30194&bhcp=1 and https://videocast.nih.gov/summary.asp?live=30198&bhcp=1.

Information Requested:

The NIH Institutes above are soliciting comments and suggestions on the top priorities identified in the five SCI 2020 breakout sessions as summarized below. The collated responses will be shared with the public and will be included in a meeting summary document prepared in collaboration with the Spinal Cord Injury Model Systems Knowledge Translation Center (https://msktc.org/about). The NIH Institutes encourage input from all interested stakeholders, including researchers, clinicians and health care providers, individuals with SCI, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, as well as other interested members of the public. Responders to this RFI are also encouraged to provide input on how the research and research capacity building in the priority areas may be adopted in low resource settings including low- and middle-income countries. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership.

 
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SCI 2020: Research Priorities:

Theme A: Improve care of SCI patients in the acute trauma setting

  • Develop an optimized approach and infrastructure for managing acute SCI:
    • Establish evidence-based medical guidelines to improve care of SCI from the time of injury, including on-site stabilization, transportation and admittance to the ER or trauma center.
    • Establish evidence-based medical guidelines to improve care of SCI in inpatient settings until discharge.
    • Evaluate how differences in care during the early period (weeks and months) after injury contribute to long-term outcomes.
    • Define and provide specialty clinical expertise needed at sites that provide acute trauma care for SCI.
    • Improve multi-directional education among clinicians, patients, family, community and peers.
  • Align preclinical studies with clinical conditions:
    • Optimize use of preclinical biomarkers and outcome measures with clinical relevance.
    • Define the clinically-feasible intervention window for promising therapeutic approaches.

Theme B: Accelerate research and development of therapies for repair, plasticity and improved functional recovery from post-acute to chronic SCI

  • Develop and use state of the art technologies that transform the way we study plasticity, circuits and repair in human SCI, as well as animal models.
  • Expand fundamental knowledge of the cells, circuits and responses to interventions to inform innovative and combinatorial repair approaches using cutting edge tools and technologies.
  • Define the specificity and requirements for axonal growth, synapse formation, cell replacement, pathway activity and/or reconstruction of circuits to support recovery at all stages post-injury.
  • Optimize efficiency and the use of data standards and data-sharing opportunities from bench to bedside and bedside to bench (including unpublished data).

Theme C: Improve evidence for, and implementation of, functional recovery with neuromodulation and use-dependent plasticity

  • Encourage longitudinal treatment studies and study designs that are informed by outcomes of high priority to individuals with chronic SCI.
  • Understand mechanisms of action and characterize variables that predict responsiveness of neuromodulation interventions in both the early post-acute and chronic conditions.
  • Facilitate data sharing and aggregation to enable data science research that can inform clinical care and improve cost effectiveness of interventions that target recovery.
  • Utilize input from individuals with SCI to identify what are acceptable risk/benefit ratios for clinical trials (modeled around the FDA’s Patient Engagement efforts).

Theme D: Improve knowledge of the full range of health impacts of chronic SCI

  • Employ multi-site and multi-disciplinary studies, with SCI consumer community input, preclinical evidence and use of common data elements to:
  • Understand the impact of behavioral, lifestyle, and environmental factors to reduce morbidity and mortality across the lifespan of people with SCI, with a special emphasis on nutrition and metabolism, activity/exercise, and lean/fat mass as a biomarker of obesity.
  • Promote safe and efficient care and recovery of bowel, bladder and sexual function; understand how infection and systemic inflammation impact all functions in individuals with SCI.
  • Understand the biology and impact of SCI on systemic health with emphasis on stressors that effect the immune function, the role of sensory and autonomic regulation, and physical and mental health outcomes.

Theme E: Improve functional recovery after SCI with assistive technology

  • Demonstrate how assistive devices can be used to promote independence and improve recovery after discharge.
  • Incorporate user input, comparative effectiveness research, and data sharing strategies to establish robust evidence for adoption of assistive technologies.
  • Improve the reliability and stability of devices and tissue interfaces to lower barriers to adoption and improve embodiment.
  • Develop approaches for assistive devices to adapt to changes in physical and developmental needs, abilities, and priorities of the user over the lifespan.

How to Submit a Response:

Responses to this RFI must be submitted electronically using the web-based form at https://www.ninds.nih.gov/RFI-NOT-NS-19-060

Responses will be accepted through July 30, 2019.

Responses are voluntary and may be submitted anonymously. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Responses may be shared publicly on an NIH website. Please do not include any personally identifiable or other information that you do not wish to make public. No proprietary, classified, confidential, or sensitive information should be included in your response.

This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States Government. The NIH will not make any awards based on responses to this RFI or pay for the preparation of any information submitted or for the Government's use of such information.

 

Inquiries

Please direct all inquiries to:

Lyn Jakeman, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-5832
Carol Taylor-Burds, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447

 

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