Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed)

The "Neuromodulation/Neurostimulation Device Development for Mental Health Applications" R01 grant, managed by the National Institute of Mental Health (NIMH), encourages innovative device development aimed at advancing brain stimulation treatments for mental health disorders. This FOA supports either novel device development or significant hardware/software enhancements to existing FDA-approved devices, emphasizing approaches that improve spatial precision, depth control, and multi-focal stimulation capabilities. Research teams are encouraged to explore advanced, closed-loop, and real-time responsive systems using both invasive and non-invasive technologies, aiming for solutions beyond incremental improvements. The focus is on devices or significant enhancements that can undergo proof-of-concept testing, including in animal models or limited human testing, though hypothesis-driven or clinical trial applications are not within scope.

This FOA seeks multidisciplinary teams that blend expertise in neuroscience, engineering, clinical applications, and regulatory knowledge. Applicants may propose device improvements that address the limitations of existing tools, such as transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT), or entirely new devices that leverage novel energy forms like ultrasound. Examples include multi-focal electrode arrays for network-based modulation, advanced EEG-stimulation systems for mobile use, and closed-loop devices that integrate neuroimaging data to inform real-time stimulation adjustments. Projects should provide a clear translational pathway, detailing potential regulatory, commercialization, and reimbursement strategies to facilitate practical application.

Eligible applicants include institutions of higher education, nonprofits, government agencies, small businesses, and other organizations, including foreign institutions. The proposed project period can extend up to five years, with budgets uncapped but required to reflect actual project needs. Applications must meet specific registration requirements and should submit through NIH’s ASSIST system, Grants.gov Workspace, or an institutional system-to-system solution. This FOA also encourages partnerships with industry, detailing any formal collaborations in the application, to enhance device development and regulatory progression.

Applications will be evaluated based on criteria including significance, innovation, and the feasibility of the approach. Reviewers will assess how well the project addresses the challenges in mental health treatment, with consideration for engineering rigor and the potential impact of the proposed technology. Other considerations include the team’s interdisciplinary capacity, integration of innovative methodologies, and concrete project milestones. An IP strategy outlining patent and ownership concerns is also required, particularly for projects involving external or collaborative resources. Successful applications should describe current technology benchmarks and how the proposed project surpasses these, ensuring comparisons with existing tools or technologies.

Key dates follow NIH’s standard cycle, with submission deadlines in February, June, and October annually until January 8, 2025. Given the high complexity and early-stage nature of projects, applicants are encouraged to contact designated NIMH Scientific/Research Contacts for guidance. Prospective applicants requesting $500,000 or more in direct costs in any year must notify NIH at least six weeks prior to submission. Data-sharing plans are required, and NIH encourages the use of common data elements to facilitate wider data use and integration across research studies.