This funding opportunity announcement (FOA) is designed to support interdisciplinary research teams of multiple PD/PIs to investigate the mechanism of action of device-based pain relief with the overall goal of optimizing therapeutic outcomes for FDA-approved or -cleared technologies. Teams must leverage appropriate multi-disciplinary expertise to develop new principles and methods for experimentation, analysis, and interpretation. Teams are encouraged to consider objectives that will produce major advances in the understanding of device-based pain relief.
This funding announcement is part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.nih.gov/.
The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.
The NIH HEAL Initiative aims to identify new, safer treatment options for pain management to improve quality of life and reduce the number of people exposed to the risks of opioids. Therapeutic devices provide a significant opportunity to offer a class of non-opioid therapies for pain that reduces or eliminates the need for opioid prescription and can provide treatment options for those who have no other effective ways to manage their pain. The outcomes of this program have the potential to ignite significant improvements in device-based clinical therapies for pain relief. Although several therapeutic devices for pain relief have received FDA Premarket Approval (PMA) or 510(k) clearance and are being disseminated clinically, many have shown variability in outcomes between individuals, or may reach a plateau in the pain relief they provide. Examples of these technologies include spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation for chronic low-back pain, transcutaneous magnetic stimulation (TMS) and vagus nerve stimulation (VNS) for migraine and cluster headache, and transcutaneous electrical nerve stimulation (TENS) for pain. Although several industry efforts to translate device-based treatments have shown success, many lack a strong mechanistic rationale from the sources of innovative basic science that the SPARC Program, BRAIN Initiative, and other NIH funding are now providing. In the case of SCS for example, the mechanism for pain relief induced by electrical stimulation is largely unknown. To address these limitations, it is necessary to better understand the mechanisms underlying medical devices for pain relief, to identify physiological markers of pain relief, and to determine how therapeutic approaches affect them. Improving this understanding will point to ways in which existing therapeutic approaches can be improved or optimized. The identification of new approaches will lead to better patient outcomes in the areas of 1) greater patient stratification by responder characteristics, 2) improved therapeutic efficacy with decreased side effects, 3) reduction in number of revision surgeries to move implanted leads, and 4) expansion of therapeutic benefits to patient populations suffering from additional sources of pain. In addition, having a broader body of knowledge in this space may lead to new, innovative ways of designing true sham-controlled efficacy trials—often a challenge for device-based therapies.
Program Approach and Scope
To accomplish these goals, applications are being solicited from interdisciplinary teams to utilize multi-faceted approaches to discovering the mechanisms of device-based pain relief for FDA-approved or -cleared therapies. Device technologies within scope of this FOA only include medical devices for pain that have already received FDA Premarket Approval (PMA) or FDA Premarket Notification 510(k). Devices that are exempt from Premarket Notification 510(k) are not within scope of this FOA. Projects should also propose/investigate methods for implementing new or optimized therapeutic procedures that have a high likelihood of improving the standard of care.
Types of research supported through this program include clinical studies and/or trials (see additional guidance below), small- or large-animal studies, and computational models. Model systems, including the possibility of multiple species ranging from invertebrates to humans, may be employed (and should be appropriately justified) in order to inform mechanistic hypotheses that can be tested in human-subjects research.
Overall, the research should be carried out by a multi-, inter-, or transdisciplinary team of researchers who will address a highly significant translational research theme or challenge in device-based pain therapies. Projects should employ multi-component teams of research expertise that seek to cross boundaries of interdisciplinary collaboration—these may include neuroscientists, clinicians, statisticians, physicists, mathematicians, engineers, veterinary scientists, computer scientists, data scientists, and others as appropriate. The goal will be to support programs with a systematic, team-science approach that can realize meaningful outcomes within the next 3–5 years. Projects are expected to result in mechanistic knowledge to inform enhanced clinical approaches with FDA-approved or -cleared devices for pain relief. Specific deliverables should include evidence-based models of pain pathways, therapeutic mechanisms of action, and/or validated computational models. Applicants are also expected to describe how the results of their studies will be disseminated widely to the public- and private-sector research communities and suggest potential implementation strategies to increase the likelihood of adoption into clinical therapies.
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