Proof of concept

Awarded activities will facilitate the translation of novel recording and modulation technologies that can be used to treat and/or diagnose central nervous system (CNS) diseases and disorders and to better understand the human CNS, from proof of concept up to the stage of readiness for first in human (FIH) studies. Technologies may incorporate any signal modality (e.g., electrical, optical, magnetic, acoustic) or a combination thereof. Diverse team-based applications that integrate appropriate domains of expertise are encouraged.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof o

NIMH funds development of new or substantially improved brain-stimulation devices for mental health research and treatment applications. Relevant work includes greater spatial or temporal precision, closed-loop control and multi-site stimulation, with proof-of-concept hardware or software development. Clinical trials are not allowed. Support is up to USD 275,000 in direct costs over two years, with a USD 200,000 annual limit. The next new-application deadline is 16 October 2026 at 5 p.m. in the applicant organisation’s local time.