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

Funding Agency:

  • National Institutes of Health
RFP# and Website: 
RFA-NS-25-022
Description: 

This NOFO is related to the recommendations in 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 recent update to the report, The BRAIN Initiative® 2.0: From Cells to Circuits, Toward Cures, recommends continuation of these ongoing efforts within BRAIN stating the need for better neurotechnology to “understand and manipulate brain function”. 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 patients 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 scale suitable for regulatory approval, yet at a price point viable for success given the constraints of the commercial markets and insurance reimbursement.

This NOFO will support a small clinical study to answer key questions about the function or final design of devices with recording and/or stimulation capabilities that both advance clinical diagnostic or therapeutic applications and maximize their scientific research value. Projects appropriate for this NOFO must have completed all non-clinical testing necessary to obtain an IDE for an SR clinical study prior to entry. Only SR studies that require an IDE from the FDA, such as chronic implants, will be supported by this NOFO. The clinical study should provide data to answer key questions about the function or final design of a device. 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 must obtain the necessary FDA and IRB approvals to conduct the clinical study prior to issuance of grant award.

This NOFO utilizes a UH3 cooperative mechanism. As a cooperative agreement, this NOFO supports milestone-driven projects and involves NIH program staff’s participation in negotiating the final milestone plan before award, monitoring the research progress, and making go/no-go decisions. The expectations of the program are in line with those of industry regarding the advancement of devices through the developmental and translational pipelines. As such, an inherent rate of attrition is possible within this program.

Applicants are strongly advised to contact the Scientific/Research contact listed below prior to submission.

C. Scope

Projects must focus on a single CNS condition that falls within the mission of one of the participating institutes of the BRAIN Initiative.

It is expected that devices used within the scope of this program either:

Awards: 

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

Budgets should rarely exceed $1,500,000 – direct costs per year.

Letter of Intent: 
60 days prior to the receipt date.
Full Proposal Submission Deadline: 

January 28, 2025

Contacts: 

Megan Frankowski, PhD 
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: NINDS-Devices@nih.gov