Translational Neural Devices (R61/R33 - Clinical Trial Optional)
Encourages translational activities and small clinical studies for neural devices to address disorders affecting the nervous system; includes prototype development, safety testing, and clinical validation.
Funder: National Institutes of Health
Due Dates: May 28, 2025 | September 29, 2025 | January 28, 2026 | May 28, 2026 | September 28, 2026 | January 28, 2027
Funding Amounts: No budget cap; project period up to 5 years (R61 ≤2 years, R33 ≤4 years); budgets must reflect actual project needs.
Summary: Supports translational and small clinical studies to advance therapeutic and diagnostic neural devices for nervous or neuromuscular system disorders.
Key Information: Milestone-driven, two-phase (R61/R33) mechanism; required attachments include Gantt chart, IP strategy, needs assessment, long-term care, and team management plan.
Description
This opportunity from the National Institutes of Health (NIH), led by the National Institute of Neurological Disorders and Stroke (NINDS), funds translational research and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders affecting the nervous or neuromuscular systems. The program is structured as a two-phase, milestone-driven R61/R33 Exploratory/Developmental Phased Award, supporting both non-clinical and clinical activities necessary to bring innovative neural devices closer to clinical adoption.
The R61 phase focuses on non-clinical activities (e.g., prototype development, safety and efficacy testing, design verification, regulatory preparation) to enable Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) clinical study. The R33 phase supports a subsequent small clinical study to generate data on device function or design that cannot be obtained through non-clinical means. NIH program staff will be actively involved in milestone negotiation, project monitoring, and go/no-go decisions.
