Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Interdisciplinary Teams to Elucidate the Mechanisms of Device-Based Pain Relief (RM1 Clinical Trial Optional)
Notice Number:
NOT-NS-21-066

Key Dates

Release Date:
June 23, 2021
Estimated Publication Date of Funding Opportunity Announcement:
August 01, 2021
First Estimated Application Due Date:
November 01, 2021
Earliest Estimated Award Date:
July 01, 2022
Earliest Estimated Start Date:
July 01, 2022
Related Announcements

None

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

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.

Research Initiative Details

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.

Funding Information
Estimated Total Funding

$20,000,000 over 5 years

Expected Number of Awards

NIH intends to fund an estimate of 3 awards in fiscal year 2022.

Estimated Award Ceiling

$2,000,000 in total costs per year up to 5 years.

Primary Assistance Listing Number(s)

TBD

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Eric Hudak, PhD
National Institute of Neurological Disorders and Stroke
301-496-1779
NINDS-Devices@nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices