SBIR-STTR Award

The low frequency cardiac rhythm (LFCR) is an innovative, but underutilized, biological marker. The PI's studies show that LFCR is strongly associated with the state of cognitive persistence in controls. Cognitive persistence refers to the ability to remain on-task and inhibit impulsive off-task behavior. Additional preliminary data also suggest that children with Attention Deficit Hyperactivity Disorder (ADHD) may have differences in LFCR during cognitive tasks. A testable biological model of angiotensin activity is proposed to explain the empirically observed correlation between LFCR and cognitive functioning. Three impediments prevent the more extensive inclusion of LFCR in research studies. First, the methodology is too complex and time-consuming for most researchers. Second, the biological basis of LFCR is inadequately understood. Third, the psychometric properties of LFCR have not been fully characterized. BioAssessments will develop a turnkey biological/assessment system that integrates biological monitoring and cognitive assessment to solve these three impediments. The goals of Phase I are to remove these three impediments to using LFCR in research. To address the first impediment, a prototype will be built that permits nonspecialists to readily monitor LFCR. To address the second impediment, two additional biological measures will be used to confirm the biological basis of LFCR: blood assays of angiotensin and Transcranial Doppler sonography (TCD). To address the third impediment, 40 elementary school children will be simultaneously monitored (LFCR, blood assays, TCD) while performing two cognitive tasks. These data will be used to characterize the psychometric properties of LFCR. The PI has demonstrated the feasibility of this concept in three prior projects with children and adults. The Phase I product will make LFCR measurements more accessible to researchers and better grounded in a biological mechanism. In Phase II, the clinical utility of the proposed product will be validated at several additional research sites. The proposed product has the potential to address a pressing clinical need for better ADHD assessment tools. In Phase III, the turnkey system would be marketed to researchers who do not have specialized psychophysiological expertise. Long-term commercial applications may include the clinical assessment of ADHD.

Thesaurus Terms:
attention deficit disorder, biomarker, cognition, diagnosis design /evaluation, heart rate, mental disorder diagnosis, psychometrics, psychophysiology angiotensin, ultrasonography clinical research, electrocardiography, human subject

The low frequency cardiac rhythm (LFCR) is a promising biological marker for psychological research. The primary goal of this project is to make the LFCR methodology more accessible to researchers by providing a both a product and extensive support services. In Phase I, a prototype system was built and used to collect simultaneous physiological and cognitive data from 41 elementary school children. The LFCR consistently decreased when children attended to computerized tasks (i.e., under conditions requiring cognitive persistence). In a preliminary pilot study, children with ADHD did not have the same decrease in the LFCR when they attempted to pay attention on the same tasks; however, they did have decreased LFCR after taking their psycho stimulant medication. A secondary goal of this project is to more firmly establish the biological underpinnings of the LFCR. Prior to the Phase I work, angiotensin activity was hypothesized to mediate the relationship between LFCR, cerebral blood flow and cognitive activity. This hypothesis was partially confirmed with the empirical evidence collected in Phase I. Blood assays validated the connection between LFCR and circulating levels of angiotensin. Transcranial Doppler sonography (TCD) data validated that connection between cerebral blood flow and LFCR. These results provide strong empirical support for the proposed biological model of cognitive persistence. This work will be expanded in Phase n through three main tasks. 1) The prototype will be further refined into a user-friendly commercial product. 2) The database of physiological changes in children and adults during cognitive performance will be enlarged using LFCR, TCD, and blood assays (adults only); ADHD participants will be tested before and after taking medication. 3) Strategic collaborations with researchers will be formed to demonstrate the value of the biological measure in other areas of research. Two impediments currently limit the use of LFCR in research studies. First, the biological basis of LFCR was inadequately characterized. The Phase I and II findings will address this limitation. Second, the methodology is too complex for most researchers without expertise in this area. BioAssessments will overcome this impediment by providing both turnkey equipment and extensive support throughout all stages of the research project. The feasibility of this business model will be demonstrated by Phase II collaborations and publications that serve as case studies. The anticipated Phase HI customer will be a researcher studying impulsivity in disorders such as Attention Deficit/Hyperactivity Disorder (ADHD) and substance abuse.