At a glance
This funding opportunity supports small, milestone-driven clinical studies of next-generation recording and/or stimulation devices for the human central nervous system, aimed at diagnosing or treating a CNS disorder and improving understanding of the human brain. It is for significant-risk studies that need FDA IDE approval and may include first-in-human or early-stage studies, including studies of already approved devices used in a new indication, target, or patient population. Eligible applicants include higher education institutions, nonprofits, and for-profit organizations, and clinical trials are optional. NIH expects about $10 million per year for an estimated 5 to 7 awards, with budgets that rarely exceed $1.5 million in direct costs per year and a total project period of up to 5 years. Projects must focus on a single CNS condition within the mission of one of the participating BRAIN Initiative institutes, and applications for non-significant-risk studies, animal studies, basic disease-mechanism research, or devices for use outside the CNS are not responsive.
What it funds
Official description from grants.gov
The purpose of this announcement is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The 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 clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device.As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm
Who can apply
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities / Indian housing authorities
- Small businesses
- Special district governments
- State governments