Notice of Intent to Publish a Funding Opportunity Announcement for BRAIN: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01)


Notice Number:

NOT-NS-15-002

Key Dates

Release Date: December 8, 2014

Estimated Publication Date of Announcement: January 2015

First Estimated Application Due Date: March 2015

Earliest Estimated Award Date: September, 2015

Earliest Estimated Start Date: September 2015

Related Announcements

RFA-NS-15-005

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The NIH BRAIN initiative (Brain Research through Advancing Innovative Neurotechnologies) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research on Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations for responsive projects.

The FOA is expected to be published in January 2015 with an expected application due date in Spring 2015.

This FOA will utilize the U01 activity code for an award with a 3 year project period. Details of the planned FOA are provided below.

Research Initiative Details

Human studies using invasive technology to record or modulate neural circuits require extensive planning and expense. As a result, these studies are often constrained by a limited number of patients and resources available to implement complex experimental protocols and are rarely aggregated in a matter sufficient to address high-impact neuroscience questions with appropriate power. Furthermore, these small scale projects rarely identify or retain additional sources of data beyond their primary endpoints, which could be of high value to the wider scientific community.

With this FOA, the NIH seeks to address these fundamental barriers by supporting planning efforts and exploratory research studies investigating high-impact questions in human neuroscience and disorders of the human nervous system. Projects should develop multidisciplinary teams to maximize opportunities to conduct neuroscience research arising from invasive surgical procedures that provide the unique ability to record and stimulate neurons within precisely localized brain structures in humans. Integrated teams should consist of clinicians, scientists, device engineers, mathematicians, statisticians, data scientists, regulatory specialists and/or ethics specialists. These teams may be assembled within a single institution, or may be integrated across multiple institutions to answer essential neuroscience questions with appropriate statistical power. Awardees will also join a consortium, coordinated by the NIH, to identify consensus standards of practice as well as supplemental opportunities to collect data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.

Applications can span the spectrum from experimental studies of mechanisms of human sensory-motor, perceptual, cognitive, mnemonic, affective, and motivational processes, to disorders of the human nervous system, to studies of mechanisms of action of device neuromodulation therapies. Applications should seek to understand circuits of the brain by systematically controlling stimuli while actively recording and manipulating relevant dynamic patterns of neural activity and by measuring the resulting behaviors and/or perceptions. Novel and innovative approaches to theory and analysis frameworks are expected to identify gaps in knowledge, and build testable hypothesis to drive the design of experiments. Applications are expected to employ approaches guided by specified theoretical constructs, and are encouraged to employ quantitative, mechanistic models where appropriate. Applications must propose appropriately-regulated, invasive studies in humans, including intra-operative procedures during therapeutic/diagnostic implantation of devices, and short- and long-term device implantation procedures. A complementary animal component to conduct reverse translation to mechanistic questions, or to perform forward translation of tools and techniques that can only be done in animal models, will be allowed.

In addition to the proposed primary study endpoints, applications should propose to solicit input from the larger community to identify and prioritize additional sources of data that could be obtained to maximize the value of these limited opportunities, as well as generate consensus on best practices and common data standards for data access and data sharing (including collection, curation, analysis and sharing).

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

James Gnadt, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: brain-initiative-FY15-FOA@mail.nih.gov