NextTech: Translational Development of Next-Generation Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications from investigators to advance the development and translation of next-generation technologies to prevent, monitor, diagnose, and treat disorders within the missions of the BRAIN and HEAL Initiatives.

Scope

The scope of this program, beginning with establishing proof of concept, may include efforts for development, optimization and pre-clinical testing that will advance next-generation technologies along the translational path up to the stage of readiness for clinical studies. Proof of concept is the initial exploration phase where the feasibility and viability of an innovative device concept are evaluated. It involves creating a prototype to demonstrate the basic functionality and potential of the idea, often without the full range of features. Applications should propose design-directed development of a new technology and not be hypothesis-driven. Devices may be non-invasive, minimally invasive, implantable, or a combination thereof. The intended use of candidate devices may be to diagnose, treat, or rehabilitate. Technologies may incorporate any signal modality such as electrical, optical, magnetic, acoustic, or any combination thereof. Devices may be used in combination with drugs, biologics, and/or small molecules, however the drugs or biologics must already be approved by the FDA.

The scope of this program excludes basic research, or studies of disease mechanism or mechanism-of-action studies. Clinical evaluation of the safety and efficacy of the intended device is beyond the scope of this NOFO. 

HEAL Initiative

This NOFO encourages applications in support 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 overdose, opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  https://www.nih.gov/heal/about-nih-heal-initiative.

As part of the mission of the HEAL Initiative, the participating NIH Institutes and Centers are encouraging the translation of early- and mid-stage technologies and approaches into new non-addictive treatments for pain and opiod use disorder (OUD). This program announcement is intended to develop new clinical-grade medical devices that are built upon a mechanistic understanding of the underlying biology. A secondary goal of this program announcement is to catalyze the development of partnerships between the academic and industrial sectors so that translational research can flourish as a cooperative, iterative process leading to safe, effective, and non-addictive treatments for pain and OUD. 

This NOFO is not specific to any pain condition. Projects to treat novel targets for acute pain, chronic pain, migraine, other headache disorders, osteoarthritis, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, pain conditions across the lifespan (including in the context of aging), etc. will be responsive. Projects to treat a combination of chronic overlapping pain conditions or for specific pathological conditions will be responsive. Projects that seek to treat novel targets in specific patient populations such as  women, older adults, and children will also be responsive and are strongly encouraged.

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.

BRAIN Initiative  

Since 2014, the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.

As one of several federal agencies involved in the BRAIN Initiative, NIH's contributions to the BRAIN initiative were initially guided by "BRAIN 2025: A Scientific Vision," a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society." This and other BRAIN NOFOs are based on this vision and issued with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group and Neuroethics Working Group.

This NOFO is part of a coordinated effort to develop "innovative technologies to understand the human brain and treat its disorders" as recommended in Section III of the BRAIN 2025 Report. The scope of this program, beginning with establishing proof of concept, may include efforts for technology development, optimization and pre-clinical testing that will advance next-generation human CNS recording and/or modulation devices along the translational path up to the stage of readiness for clinical studies.