Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
Companion Funding Opportunity: PAR-22-039 , R01 Research Project
Brief Description: This Funding Opportunity Announcement (FOA) encourages the development of novel brain stimulation devices and accompanying software/hardware additions that enable improved delivery of brain stimulation treatments for mental health indications. Applications should be submitted by multi-disciplinary teams with expertise in systems neuroscience, engineering, clinical, and regulatory affairs and promote either the development of novel tools (hardware/software) or significant enhancement of existing tools (hardware/software). Applications should be engineering/pre-clinical based and focus on hardware and software development and validation. Although the application should focus on the engineering development of the tool, animal and limited, non-clinical trial, human testing to demonstrate initial proof of concept is allowable. Applications that seek to study specific scientific or clinical hypotheses that utilize devices are outside the scope of this FOA. The R21 grant mechanism of this FOA is to encourage high risk, proof of concept, applications that may lack preliminary data, or smaller projects that are closer to final form and do not require longer time for development and innovation.
Applications may propose to develop novel invasive or non-invasive brain stimulation devices. New devices should be designed to significantly advance the field and go beyond current stimulation and low-channel count recording/stimulating capabilities. Existing magnetic and electrical stimulation methods have limited spatial and temporal precision. To overcome these obstacles and move beyond incremental advances, collaborations between physicists, engineers, neuroscientists, and clinicians are encouraged. The perspective and expertise of such integrative teams could enable the development and testing of novel approaches that leverage other types of energy or stimulation methods in a way that can lead to novel tools for scientific discovery and for therapeutic brain stimulation. Applications that propose to improve spatiotemporal precision, stimulate at depth, enable multi-focal recording/stimulation, and utilize novel stimulation paradigms are encouraged. Appropriate modeling and preliminary data should be presented to demonstrate the feasibility of the stated approach. While the application may be in the initial stages of device development and may therefore still be in the animal testing phase, the proposed tools and methods must be designed for use in humans. Animal testing should focus on questions of safety. Industry partnership is encouraged and should be detailed in the application. The regulatory process for the new technology should be described in the application, when applicable.
Applications may also propose to develop additional capabilities for existing FDA-approved or cleared brain stimulation devices and related technologies. However, proposed improvements to existing devices and related technology should be significant and innovative, rather than incremental. Appropriate improvements may include: 1) incorporating advanced approaches to stimulation delivery, such as real-time realistic head/electric field modeling that incorporates patient-specific tractography or cellular-level resolution; 2) synchronizing behavioral recordings with brain recordings in novel ways; or 3) developing novel delivery methods, such as augmented and virtual-reality approaches. For existing devices, approaches that seek to improve the focality and depth of stimulation, controllability of the delivered dose, sham control delivery, or recording capabilities are encouraged. Software approaches that seek to develop novel approaches (e.g., machine learning) to biomarker-driven targeted delivery of stimulation are also encouraged.
The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
February 16, 2022
David McMullen, M.D.; National Institute of Mental Health (NIMH); Telephone: 301-451-0180; Email: david.mcmullen@nih.gov