The NIH funding opportunity titled Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed) supports long-term projects aimed at creating or significantly enhancing brain stimulation devices for treating mental health disorders. Applicants may propose novel device development or transformative advancements in existing FDA-approved or cleared devices, with a focus on engineering innovation. Applications must be integrative and design-directed, featuring multidisciplinary teams from fields such as engineering, neuroscience, and regulatory affairs. The maximum project period is five years, with budgets reflecting actual project needs.

The initiative addresses limitations in current brain stimulation devices, seeking breakthroughs in spatiotemporal precision, multi-focal capabilities, and closed-loop technologies. Projects can include animal and limited human testing for proof-of-concept. Industry partnerships are encouraged to aid in device development and regulatory pathways. Applicants must describe a clear translational plan, including commercialization and regulatory strategies.

Eligibility is broad, encompassing higher education institutions, nonprofits, for-profit organizations, and government entities, both domestic and foreign. Applicants must complete registrations with SAM.gov, Grants.gov, and eRA Commons. Proposals must include a Plan for Enhancing Diverse Perspectives (PEDP) detailing actionable strategies to improve inclusivity, a data management plan, and an intellectual property strategy addressing the development and use of the proposed device.

The evaluation criteria emphasize scientific merit, innovation, feasibility, and the expertise of the research team. Proposals should demonstrate potential for significant impact, detail milestones, and address challenges such as intellectual property barriers. Applications must also highlight how inclusivity will enhance the scientific and technical merit of the project.

Key dates include the earliest submission opening on January 5, 2025, with rolling deadlines through 2027. Funding decisions will be based on scientific merit, alignment with program priorities, and budget considerations. Applicants requesting $500,000 or more in direct costs annually must contact NIH officials at least six weeks prior to submission.

The NIH encourages proactive engagement with program officers and adherence to the NIH application guidelines. Detailed instructions and additional requirements for data sharing, animal research, and human subjects research are outlined in the program announcement.