Clinical Neuroscience and Entertainment Software Pilot Partnership Program to Develop Neuropsychiatric Interventions (R43/R44)
Grant Amount: Approximately $3,000,000 in FY 2014 to fund three to six awards.
This Funding Opportunity Announcement (FOA) utilizes the Small Business Innovation Research Program (SBIR) award mechanism to support the development of highly engaging cognitive training interventions delivered through computers and/or gaming platforms that are targeted to the treatment of neuropsychiatric disorders, autism and/or HIV Associated Neurocognitive Disorders (HAND), with the goal of improving real-world functioning of patients. This initiative specifically supports small businesses with development and commercial experience in the entertainment software industry to partner with clinical neuroscientists experienced with cognitive training.
This NIMH SBIR FOA is informed by two recent meetings: (1) the inaugural meeting of the Entertainment Software and Cognitive Neurotherapeutics Society (ESCoNS) in September 2011, where representatives from the entertainment software community, neuroscientists, and the NIH came together to establish potential partnerships for the development of cognitive neurotherapeutics; and (2) the NIMH-sponsored meeting “Cognitive Training in Mental Disorders: Advancing the Science” in April 2012, which focused on next steps in the further development, validation and implementation of cognitive training interventions, including a focus on novel and multi-component interventions and new therapeutic targets.
It is expected that products developed from this FOA will be drawn from interventions with demonstrated efficacy and a strong scientific rationale for the treatment target and intervention modality. Highest priority will be given to interventions that target functional domains implicated in neuropsychiatric disorders (e.g., attention, working memory, social cognition, affect regulation, attention bias), and the neurocircuitry underlying the targeted domain. A strong scientific justification for the choice of neuropsychiatric disorder and age of research participants is also required.
It is expected that the proposed partnerships would include groups with demonstrated track records in the areas of neural plasticity and cognitive training research, and the successful development and commercialization of entertainment software programs. Phase I of this pilot program would serve as a vehicle for the primary research and development, and will include initial feasibility testing. It is expected that at the completion of Phase I the applicant will have developed a working prototype. In Phase II, it is expected the applicant will formally evaluate the product utilizing an appropriately powered efficacy study that includes validated cognitive outcome measures and validated measures of functional outcome. The applicant should also ensure the final product is in compliance with FDA regulatory guidelines, by initiating the pre-IDE process: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm#pre_ide.
US Department of Health and Human Services Public Health Services National Institutes of Health National Institute of Mental Health
Number of Awards Given
3 - 6 awards
Award Amount Notes
The NIMH intends to commit approximately $3,000,000 in FY 2014 to fund three to six awards. Future year amounts will depend on annual appropriations.
Letter of Intent Date
Application Due Date
Project Start Date
Grants.gov Customer Support , Phone: (800) 518-4726
Durations up to two years for Phase I and up to three years for Phase II may be requested.
HIV Positive Persons Neurological Diseases or Disorders Program Development Psychological Factors
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf), except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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