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National Institute of Neurological Disorders and Stroke (NINDS)
In April 2018, the National Institutes of Health (NIH) launched the Helping to End Addiction Long-termSM Initiative or HEAL InitiativeSM, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. As part of this initiative, the National Institute of Neurological Disorders and Stroke (NINDS), with other NIH Institutes and Centers (ICs) of the HEAL Initiative, intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications from interdisciplinary teams to elucidate the mechanisms of device-based pain relief.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOA is expected to be published in Summer 2021 with an expected application due date in Fall 2021.
This FOA will utilize the RM1 activity code. Details of the planned FOA are provided below.
Through targeted research efforts, the NIH HEAL Initiative aims to support the development of safe and effective therapies to treat pain with little or no addiction liability. This Notice encourages investigators with expertise and insights into the pathophysiology of pain or medical devices for the treatment of pain to begin to consider applying for this new FOA.
While there are many FDA-approved or FDA-cleared medical devices to treat pain available commercially and in widespread clinical use (e.g. spinal cord stimulators, vagus nerve stimulators, transcranial magnetic stimulation devices, dorsal root ganglion stimulators, and transcutaneous electrical nerve stimulation devices), many devices lack a strong mechanistic rationale for how they work, and patients experience a wide range of outcomes with some reaching a plateau in the pain relief they can achieve. Through this FOA, we aim to achieve the following goals: 1) gain an understanding of the mechanisms underlying device-based pain relief, 2) identify physiological markers of pain relief, 3) determine how stimulation affects those markers, and 4) identify new approaches to significantly improve care. By gaining a clearer understanding of the mechanisms by which FDA-approved or -cleared devices relieve pain, optimized therapeutic approaches can be designed and implemented that will lead to significant improvements in patient outcomes. To accomplish these ambitious goals, this FOA will support research from multi-PI interdisciplinary teams of complementary expertise to discover the mechanisms of device-based pain relief. In order to maximize creativity and progress, collaborative investigations combining expertise in fields such as neuroscience, clinical research and practice, veterinary science, engineering, physics, mathematics, statistics, computer science, and/or data science will be encouraged and these investigators should also begin considering applying for this application.
Among the areas of research encouraged in this initiative are small- and/or large-animal studies, computational modeling, and clinical studies or trials focused on examining the mechanisms of device-based pain relief, as well as research designed to improve the translation of existing knowledge of strategies for the prevention and treatment of acute and chronic pain. Clinical studies or trials can be included to determine the neuromodulatory or neurophysiological mechanisms of a device intervention.
Potential deliverables from projects supported by this FOA include evidence-based models of pain pathways, therapeutic mechanisms of action, validated computational models, optimized clinical approaches, and proposed implementation strategies to increase the likelihood of adoption of concepts into clinical practice.
$20,000,000 over 5 years
NIH intends to fund an estimate of 3 awards in fiscal year 2022.
$2,000,000 in total costs per year up to 5 years.
TBD
Applications are not being solicited at this time.
Please direct all inquiries to:
Eric Hudak, PhD
National Institute of Neurological Disorders and Stroke
301-496-1779
[email protected]