A precision functional neuroimaging platform to enable collection of highly-sampled data at home

The goal of this Phase I STTR is to enable the commercial readiness of an imaging platform for precision mental health. Despite significant federal investment, the translation of functional brain imaging technologies into clinical psychiatry remains elusive. Current methods, such as functional Magnetic Resonance Imaging (fMRI) and Electroencephalography (EEG), show poor reliability and reproducibility, in large part due to reliance on group-averaging and short-duration recordings. Accumulating evidence suggests that larger quantities and durations (i.e., highly sampled) of data are needed to fulfill the promise of functional neuroimaging in clinical psychiatry. Objective, highly reproducible measurements of brain function would empower clinicians and researchers to make more accurate characterization of mental illnesses and reliable monitoring of treatment efficacy. One way to meet the need for highly sampled data collection is to enable data collection by patients themselves or their parents/caregivers, out of the lab (e.g., at home), similar to at-home blood pressure monitoring. Unfortunately, current methods cannot scale because they are too costly and impractical. To this end, our interinstitutional, multidisciplinary team of experts in engineering, neuroscience, psychiatry, UX and software design has developed a functional prototype of a precision mental health platform appropriate for at-home use. The prototype integrates a low-cost, wireless, multi-sensor, wearable functional near infrared spectroscopy (fNIRS) device with a tablet app that delivers standard, neuroimaging-ready cognitive tests through a HIPAA-compliant cloud portal for researchers and clinicians to remotely monitor patient’s brain response during long sessions spanning multiple days or weeks. Importantly, our platform’s unique strategy for self-alignment and ultra-low cost are key features to enable scalable, at-home use by patients with high data accuracy. In contrast, hurdles of cost and usability limit scalability for at-home use of other commercial and emerging fNIRS systems, which are largely designed for use by researchers. Our preliminary study to collect highly sampled data in a small cohort of healthy adults in a home-like setting with our prototype showed (1) data reliability improves significantly with longitudinal use and (2) we can extract robust and reproducible individual- and group-level findings. In preparation for commercialization, this proposal aims to overcome two technical hurdles needed to ensure reliability of the data collected by patients at home: (Aim 1) Modify the prototype design for reliable data acquisition across inclusive physical differences such as varying head size and skin tone; (Aim 2) Evaluate the feasibility and usability of the developed platform in an at-home study. While our system is generalizable for a variety of illnesses and disorders, here we will validate its clinical relevance for attention deficit hyperactivity disorder (ADHD), a model disorder due to its clinical high significance, brain target accessibility and ease of recruitment. If successful, our Phase II proposal will aim to modify the device for scalable manufacturability and carry out larger clinical validation studies. Project Number: 1R41MH139347-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: Ali Rahimpour Jounghani (+1 co-PI) | Institution: WALNOT, INC., NEWARK, DE | Award Amount: $449,390 | Activity Code: R41 | Study Section: Special Emphasis Panel[ZRG1 NV-C (10)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11195446