Patron members sought for project engagement
Activity-based therapies (ABT) help people with SCI/D improve function of the legs, arms, bowel, bladder and heart. However, ABT is rarely used in hospitals because of time constraints. This project is part of a broader research project to develop of standardized guidelines and a tracking tool to specifically measure neuro-recovery in Activity-based Therapy (ABT) will enable the collection of data to appropriately determine:
- How outcomes in ABT differ from traditional rehabilitation approaches.
- Factors affecting outcomes in ABT (age, time post injury, level and severity of injury etc.,
- Benchmarks for optimal dosing of intensity and frequency based on recovery profiles.
- Health economics data to support implementation into our neurorehabilitation centers. The NASCIC partnership will ensure the input of people with lived experience as well as caregivers/family members with lived experience are provided throughout the development stages of the ABT tracking tool and guidelines.
This project is led by the team at the University Health Network and KITE in Toronto.
This project is led by the University of Minnesota to identify the impact of the COVID-19 pandemic on individuals living with spinal cord injury (SCI) with respect to both medical rationing and access to personal care attendants. They are recruiting for an online and telephone-based survey to assess the impacts of the COVID-19 pandemic on the spinal cord injury community.
This project is for NASCIC to work with a research & development organization to build a fully integrated brain-machine interface (BMI) system that will enable a computer or other digital devices to communicate directly with the brain.
The first application will be to assist people living with paralysis, particularly individuals with tetraplegia who have limited ability to manually interact with external devices. Later, the software could be used with a range of other assistive devices, including wheelchairs, assistive robots or even systems for functional electrical stimulation (FES) of muscles or the spinal cord.
This project is designed with the importance of engaging the user community early in the development process. The work with NASCIC will help to ensure that community input shapes both the device being developed and the route to clinical testing and regulatory approval. This project includes a Consumer Advisory Board, Focus Groups and Community Survey.
This project is intended to assess how people living with SCI access timely and reliable information about newer therapeutic interventions and clinical trials. It struck the authors that: a) many people with SCI may not be aware of emerging therapies and technologies; b) may be subject to “scam” information about therapies and interventions that aren’t proven to be effective; and c) may have unmet needs for unbiased information about treatments and trials.
The project focus is to develop and distribute a survey directed toward the SCI community. The survey is meant to help our team understand how people living with SCI access and evaluate information about newer medical/therapeutic treatments and opportunities to participate in clinical trials.
In a time of great hope for recovery from SCI, we are specifically interested in how people living with injuries determine which information they receive seems true and credible and which does not.
An advisory board of people with SCI lived experience were recruited and engaged in this project. This project is led by Micheal Stillman of Jefferson University. Initial results were published the Journal Spinal Cord Series & Cases titled “How individuals with spinal cord injury in the United States access and assess information about experimental therapies and clinical trials: results of a clinical survey.”
Despite decades of discussions within the SCI community, efforts to form a comprehensive SCI national registry have been largely unsuccessful. Currently, several SCI datasets exist in the United States including the National Spinal Cord Injury Statistical Center database (utilizing data from SCI individuals admitted to rehabilitative programs within the SCI Model Systems of Care network), the VA SCI and Disorders Outcomes System, as well as a patchwork of individual state databases.
There are variations in size, criteria for inclusion, purpose, data elements and collection platforms meaning data on the entire SCI population is not captured, nor is it captured uniformly. The recently passed (2016) legislation “Advancing Research for Neurological Diseases Act of 2016 included in the 21st Century Cures Act of 2016’’ [page 1076] which was funded in 2018, gives NASCIC members the opportunity to inform the Centers for Disease Control & Prevention (CDC) of the strategic importance of a spinal cord injury (SCI) national registry. NASCIC will set appropriate SCI data fields to be collected using CDC’s lessons learned in phases one and two of the National Neurological Conditions Surveillance System to ensure that the resulting SCI database will serve policymakers, medical equipment and medical supplies providers and the overall SCI community as a whole.
A diverse team of people with lived experience and representatives from various SCI database managers was formed for this project. This project is led by United Spinal Association.
How do you feel about people accessing your research data? Dr. John Kramer’s lab at ICORD and NASCIC have partnered to work on a research study examining how people with a spinal cord injury feel about their research data used by others. Data sharing is the idea of re-using anonymous, de-identified data from previous research in new ways, whether that be in new research done at a university, in policy creation in government, or even examining medication effects at pharmaceutical companies.
This project involves several steps: First, a focus group will be formed to identify key areas of data sharing that should be examined. This information will lead to the creation of a data sharing survey, which will be disseminated across North America. The survey findings will then be analyzed, and results will be published as an academic paper and as a position statement that can guide data sharing policies. The key driving force behind this project is to hear from people living with spinal cord injury, their families, and their community, and to get their voices and beliefs about how their own research data should be treated.
This project is to recruit people living with SCI and their caregivers and family members to join the Mid-Atlantic SCI Research Network as advisors. Four to five individuals from the SCI community will be part of an on-going Advisory team to this collaborative research group.
Participating research centers currently include Inova Health System, University of Pittsburgh Medical Center, and Johns Hopkins University Medical Center. The Network is organized to include the broadest geographical area defined by the “Mid-Atlantic” region, namely, the states of New York, Pennsylvania, New Jersey, Delaware, Maryland, Virginia, West Virginia, and the District of Columbia. The Mid-Atlantic SCI Research Network, which includes regional academic partnerships, including rehabilitation and care centers, is being established to run clinical trials in SCI in that region in a more efficient and more robust manner.
The SCI community advisory group will assist in crafting the inclusion criteria for individuals to be recruited to the network clinical trials and work with research coordinators for different projects. In addition, clinical trial logistical issues, such as SCI participant and caregiver transportation, home visitation, etc. will need to be addressed with the guidance of the advisory group. Those serving on the advisory team are considered partners in the research projects of the network and provide a perspective of those living with SCI.
This project aims to create an Advisory Team comprising 4-6 people living with SCI with diverse perspectives to collaborate with the Robotic Exoskeleton for Increased Mobility Working Group.
This project is led by representatives from the Florida Institute for Human & Machine Cognition (IHMC) and Myolyn as part of their Discovery Award for the Toyota Mobility Unlimited Challenge. The high-level vision for this exoskeleton is a self-balancing, semi- autonomous, hands-free, highly mobile device that will increase mobility for people with lower limb paralysis.
The role of the Advisory Team will be to help identify and define the mobility goals of individuals with lower limb paralysis and provide a critical perspective for creating a road map that balances individuals’ needs, concerns, preferences, and goals with available and emerging approaches to address them. The project is one of the finalists for the Toyota Mobility Unlimited Challenge.
Integrated KT (IKT) is an approach to doing research whereby research users as partners alongside researchers throughout the entire research process. The resulting research is more applicable, useful and translatable to end-users than research conducted by researchers alone. Despite the advantages of an IKT approach, only a small minority of KT activities have been planned and implemented in partnerships between researchers and the community.
SCI researchers have often been accused of tokenism (i.e. people with SCI are asked to only endorse research to legitimize research programs over which they have little real control) and recent calls have highlighted the need for further support for SCI researchers and research users adopt IKT partnerships. While recommendations for adopting IKT approaches have been put forth, these recommendations are not informed by a process that uses a rigorous methodology (e.g. systematic review) and meaningful engagement of SCI stakeholders to develop IKT best practices.
The objective is to develop and implement the first IKT guiding principles for conducting and disseminating research in partnership with the SCI community. Several members of NASCIC are members of this consensus panel providing input as stakeholders, potential advocates, and adopters of the principles.
This project is led by Heather Gainsforth from the University of British Columbia. The latest manuscript was published in the Archives of Physical Medicine and Rehabilitation, “Integrated Knowledge Translation Guiding Principles for Conducting and Disseminating Spinal Cord Injury Research in Partnership.”
The FDA division of the Center for Device and Radiological Health (CDRH) have a pilot program to directly engage with advocacy organizations. The program is called this Patient & Caregiver Connection Program (PCC). NASCIC is one of fifteen organizations invited to be involved with the pilot program. During this test phase, we work with the PCC program to help the program evolve to include more patient organizations.
The PCC was formed as an intentional and meaningful interaction with the patient population and the program is housed in the Office of Strategic Partnerships and Technology Innovation (OST). There are 3 goals to gain an understanding of:
- living with a specific disease or condition
- how medical devices are used for diagnosis, treatment, or management of a patient’s disease or condition
- current issues or trends related to medical devices
The operation of the program is a simple feedback loop between PCC and the involved organizations. The OST contacts the PCC representatives with areas that need a greater understanding, then CDRH will issue key questions to the involved organization. These questions are disseminated to their constituents to gain feedback and the results and ancillary commentary is looped back to CDRH. This is a step in the right direction to have our voice heard within the FDA and to engage with them directly. The NASCIC liaison will be Jen French and will report periodically on updates from the FDA and active communication opportunities directly with the agency.
Within the mission of the North American SCI Consortium is to bring unified achievements in both research and policy. A key funding agency of SCI research is the National Institute of Neurological Disorders and Stroke (NINDS), which is an institute within the National Institutes of Health in the United States. NINDS spends approximately $80M per year on research dedicated toward spinal cord injury. Within each institute is a national advisory council consisting of established research scientists and academics.
The National Advisory Neurological Disorders and Stroke (NANDS) Council has two general functions: (1) to advise the NINDS on policy and procedures affecting the extramural research programs and (2) to provide a second level of review for all grant and cooperative agreement applications considered by the Institute for funding. They meet 3 times per year. More about the NANDS Council may be viewed here (https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Advisory-Council).
NASCIC members have decided there is a need to advocate for a redistribution of the research funding to have more emphasis on
- chronic injury
- translational and clinical research to improve care and quality of life
- incorporating the input and voice of those living with SCI and their caregivers in the entire process
This project created an Advisory Team comprising 5-6 people living with SCI to collaborate with the Neuromodulation for Bladder and Bowel Working Group. Initiated by the Craig H. Neilsen Foundation Neurogenic Bladder and Bowel Workshop, this Neuromodulation Working Group was created out of a team of approximately 12 individuals from research, industry, clinical, and advocacy organizations to explore neuromodulation interventions for bladder and bowel function for individuals living with SCI.
The goal of the Working Group is to promote adaptation and translation of neuromodulation technologies to meet the functional goals of individuals with neurogenic bladder and bowel dysfunctions within a 10-year timeframe. The role of the Advisory Team was to help identify and define the bladder and bowel goals of individuals with SCI, and provide a critical perspective for creating a road map that balances individuals’ needs, concerns, preferences, and goals with available and emerging neuromodulation approaches to address them.
This was accomplished by surveying NASCIC members and incorporating their feedback into a written document. The survey results were published in the Journal Spinal Cord titled “ Needs, priorities, and attitudes of individuals with spinal cord injury toward nerve stimulation devices for bladder and bowel function: a survey” .
A complementary article was also published in the Journal Spinal Cord titled “A roadmap for advancing neurostimulation approaches for bladder and bowel function after spinal cord injury.”