Notice of Intent to Publish a Funding Opportunity Announcement for the BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3)


Notice Number:

NOT-NS-15-007

Key Dates

Release Date: December 17, 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

None

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 (Brain Research through Advancing Innovative Neurotechnologies) Initiative intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System.

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 UH3 mechanism to support small clinical studies that will advance next generation recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Projects appropriate for this FOA 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. The total duration of the award may not exceed 5 years. A companion FOA is also expected to be published in January 2015, which will support non-clinical testing required to obtain the necessary approvals to conduct the clinical study, in addition to a singular clinical study.

A summary of the planned FOA is provided below.

Research Initiative Details

This FOA is related to Section III of the BRAIN 2025 Report, and addresses the goal of developing 'innovative technologies to understand the human brain and treat its disorders'. The NIH recognizes that initial first-in-man studies are a key point in the development of innovative new clinical technologies. The leap from animal studies to humans is large, and initial clinical studies are often necessary to address critical scientific questions about the function of a device in human subjects and/or inform a final device design suitable for eventual FDA market approval. Initial demonstrations of novel device function in humans have become increasingly required to encourage the industry and venture capital investment necessary to develop a final safe, reliable, and efficacious device that can be manufactured at a scale suitable for regulatory approval, yet at a price point sufficient for sustainable commercial market given insurance reimbursement.

The purpose of this FOA is to encourage applications to pursue a small clinical study 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, 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 nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Examples of the types of clinical studies that can be proposed 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 subjects
  • Studies of the key physiological variables that may impact the function of the device in humans
  • Initial assessments of device safety, but only in conjunction with obtaining enabling data about device design or function.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Kip Ludwig, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
Email: brain-initiative-FY15-FOA@mail.nih.gov