BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Required)

Funding Agency:
National Institutes of Health

 The purpose of this Funding Opportunity Announcement (FOA) 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 https://braininitiative.nih.gov/resources/brain_ppp/index.htm

Individuals, institutions or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to RFA-NS-18-021 or this FOA.

Deadlines:

  • Letter of Intent: 30 days prior to the receipt date
  • Application Due Date(s): February 23, 2018, June 21, 2018, October 22, 2018, February 21, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020 , and February 22, 2021

RFA-NS-18-022 Expiration Date New Date February 23, 2021 per issuance of NOT-NS-20-105. (Original Expiration Date: October 22, 2020)

Agency Website

Amount Description

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Budgets should rarely exceed $2M per year.

The total duration may not exceed 5 years. 

    Funding Type

    Grant

    Eligibility

    Faculty

    Category

    Engineering and Physical Sciences
    Medical
    Medical - Basic Science
    Medical - Clinical Science
    Medical - Translational

    External Deadline

    February 22, 2021