Notice Number: NOT-NS-18-052

Key Dates
Release Date: March 27, 2018

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to inform potential applicants to the National Institute of Neurological Disorders and Stroke (NINDS) Bioengineering Research Grants (BRG), Bioengineering Research Partnerships (BRP), Translational Neural Devices, and BRAIN Initiative: Next Generation Invasive Devices Recording and Modulation in the Human Central Nervous System, and Smart and Connected Health Funding Opportunity Announcements about an area of special interest. NINDS would like to accelerate the development of devices for the treatment of pain. Investigators are strongly encouraged to contact the appropriate Program Director prior to submitting an application. Applications may be submitted to: PAR-18-206 (BRG), PAR-18-208 (BRP), RFA-NS-18-011 (Translational Neural Devices), RFA-NS-18-012 (Translational Neural Devices - SBIR), RFA-NS-18-021 (BRAIN Initiative), RFA-NS-18-022 (BRAIN Initiative), RFA-NS-18-023 (BRAIN Initiative - SBIR), and NSF-18-541 (Smart and Connected Health).

Within the BRG and BRP programs, NINDS is particularly interested in bioengineering research that advances technologies with the potential to decrease the burden of neurological disorders and stroke, including pain. Examples of areas of interest include the development and validation of invasive and non-invasive devices, diagnostic/monitoring tools, advanced imaging techniques, computational models, tissue engineering, and other innovative methods.

The Translational Neural Devices program is interested in receiving applications for translational studies on devices to treat pain. Translational Neural Devices supports translational activities and small clinical studies to advance the development of invasive and non-invasive therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Program activities, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. This program will also support the subsequent small clinical trial to collect safety and effectiveness data required to support a marketing application or to inform final device design.

The BRAIN Initiative: Next Generation Invasive Devices Recording and Modulation in the Human Central Nervous System program supports translational and/or clinical studies for invasive recording and/or stimulating devices to treat nervous system disorders, including support for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and/or a small clinical trial (e.g., Early Feasibility Study). The small clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The BRAIN Initiative includes both the brain and spinal cord and this program would like to encourage translational and clinical projects for invasive recording and/or stimulating devices to treat pain.

The Smart and Connected Health program (https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504739) is an interagency program between the Institutes and Centers of the National Institutes of Health (NIH) and the National Science Foundation (NSF) supporting the development of technologies, analytics and models supporting next generation health and medical research through high-risk, high-reward advances in computer and information science, engineering and technology, behavior, cognition, robotics and imaging. NINDS is interested in applications for next-generation multidisciplinary science that encourages research in pain in a variety of areas of value to health, such as networking, pervasive computing, advanced analytics, sensor integration, privacy and security, modeling of socio-behavioral and cognitive processes and system and process modeling.

Inquiries

Please direct all inquiries to:

Nick Langhals, Ph.D.
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1447
Email: nick.langhals@nih.gov

Stephanie Fertig, M.B.A.
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1779
Email: fertigs@ninds.nih.gov

Michael Oshinsky, Ph.D.
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-9964
Email: michael.oshinsky@nih.gov