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

    This grant supports developing advanced brain stimulation devices for mental health treatment, focusing on novel techniques with improved precision and efficacy.

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    Funder: National Institutes of Health

    Due Dates: June 5, 2025 (New) | July 5, 2025 (Renewal/Resubmission/Revision) | October 5, 2025 (New) | November 5, 2025 (Renewal/Resubmission/Revision) | February 5, 2026 (New) | March 5, 2026 (Renewal/Resubmission/Revision) | June 5, 2026 (New) | July 5, 2026 (Renewal/Resubmission/Revision) | October 5, 2026 (New) | November 5, 2026 (Renewal/Resubmission/Revision) | February 5, 2027 (New) | March 5, 2027 (Renewal/Resubmission/Revision) | June 5, 2027 (New) | July 5, 2027 (Renewal/Resubmission/Revision) | October 5, 2027 (New) | November 5, 2027 (Renewal/Resubmission/Revision)

    Funding Amounts: No budget cap; budgets must reflect actual project needs. Maximum project period: 5 years.

    Summary: Supports development of next-generation brain stimulation devices for mental health, emphasizing novel technologies or significant enhancements to existing FDA-approved devices.

    Key Information: Clinical trials are not allowed; applications must focus on device/tool development, not hypothesis-driven clinical studies.


    Description

    This NIH opportunity invites applications to develop innovative neuromodulation or neurostimulation devices for mental health applications. The focus is on either (1) creating novel brain stimulation devices that move beyond current electrical/magnetic approaches, or (2) making significant, non-incremental hardware/software improvements to existing FDA-approved or cleared devices. The goal is to enable new or substantially improved capabilities for treating mental health disorders, such as increased spatiotemporal precision, multi-focal or closed-loop stimulation, and enhanced depth or targeting.

    Projects should be engineering- and preclinical-focused, with allowable activities including device design, bench testing, animal studies, and limited non-clinical trial human testing for proof of concept. Incremental changes (e.g., simple software updates) and studies that simply use existing devices to test clinical hypotheses are not within scope.


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