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

 
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    CFDA#

    93.853; 93.865; 93.866; 93.286; 93.867; 93.173; 93.273; 93.279; 93.242; 93.213
     

    Funder Type

    Federal Government

    IT Classification

    B - Readily funds technology as part of an award

    Authority

    U.S. Department of Health and Human Services (HHS), National Institute of Neurological Disorders and Stroke (NINDS)

    Summary

    This program utilizes a UH3 cooperative agreement mechanism to support a small clinical study to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system (CNS) disorders and better understand the human brain. 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 study 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 study 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, yet is critical to enable next-generation diagnostic or therapeutic devices.

    Projects appropriate for this program must have completed all non-clinical testing necessary to obtain an Investigational Device Exemption (IDE) for a Significant Risk (SR) clinical study or obtained Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) clinical study prior to entry.  In addition, projects must obtain the necessary approval to conduct the clinical study prior to entry or within the first year of the award.

    A companion program, RFA-NS-16-009, will support non-clinical testing required to obtain the necessary approvals to conduct the clinical study, in addition to a singular clinical study.

    This program is milestone-driven and involves NIH program staff's participation in developing the project plan, monitoring the research progress, and making go/no-go decisions. NIH staff will also provide assistance to academic investigators in familiarizing them with the clinical device development process and the criteria needed to advance therapeutic leads and diagnostics to the clinic.  The expectations of the program are in line with those of industry in regards to advancing devices through the translational developmental pipeline.  As such, an inherent high rate of attrition is expected within this program.  

    For entry to the program, projects should have:

    • Comprehensive Supporting Data: Proof-of-concept data of device function are required using a prototype device equivalent to the final device design anticipated for clinical testing, ideally obtained using an in vivo model representative of the intended patient population;
    • Completed all non-clinical testing necessary for approval to conduct the clinical study;
    • A compelling case for a successful IDE submission to support the clinical component, or IRB approval for an NSR study, within the first year of the award;
    • Overall device development plan, including timeline for contact and interaction with appropriate regulatory bodies, clinical considerations, and a needs assessment; and
    • Identification of one or more clinically meaningful device outcome measures based on input from both clinicians and patients


    The program will support a small clinical study to answer key questions about the function or final design of a device. Examples of studies that can be proposed during the clinical phase include, but are not limited to:

    • Optimization of the device design with respect to the human functional anatomy;
    • Identification of the most simple, reliable, and cost effective device configuration for more advanced clinical trials and eventual market approval;
    • Basic proof-of-concept testing in human patients;
    • Studies of the key physiological variables that may impact the function of the device in humans; and
    • Initial assessments of device safety are expected, but only in conjunction with obtaining enabling data about device design or function
     

    History of Funding

    None is available. 

    Additional Information

    The following activities will not be supported:

    • Basic research and studies of disease mechanisms;
    • Animal model development: All in vivo models must have been previously established and characterized;
    • Non-clinical testing necessary to support regulatory approval;
    • Rehabilitation strategies;
    • Imaging technologies;
    • Definitive clinical trials of therapeutic devices, such as a traditional Feasibility study and/or Pivotal Trial;
    • Efforts to develop neurotechnology for fundamental study of the CNS;
    • Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses are not responsive to this program but may be within scope of future BRAIN programs; 
    • Projects focused on augmentation of neural function in healthy individuals; or
    • Technologies intended for implant outside of the CNS

    Contacts

    Tijuanna E. DeCoster, PhD

    Tijuanna E. DeCoster, PhD
    U.S. Department of Health and Human Servicdes
    National Institute of Neurological Disorders and Stroke
    P.O. Box 5801
    Bethesda, MD 20824
    (301) 496-9231
     

  • Eligibility Details

    Eligible applicants include:

    • Higher Education Institutions;
    • Nonprofits Other Than Institutions of Higher Education;
    • For-Profit Organizations;
    • Governments;
    • Independent School Districts;
    • Public Housing Authorities/Indian Housing Authorities;
    • Native American Tribal Organizations (other than Federally recognized tribal governments);
    • Faith-based or Community-based Organizations; and
    • Regional Organizations

    Deadline Details

    Applications must be electronically submitted via Grants.gov by 5:00 PM local time of applicant organization on April 26, 2016.

    Award Details

    Approximately $13,500,000 is anticipated to be available in total funding for FY16 to fund 4 to 7 awards. Awards will be up to $2,000,000 per year and will last up to 5 years. Cost sharing/matching is not required. 

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