Development of an Objective Pain Biometric Device and Method

The objective of this Phase I SBIR is to establish the proof of concept for a device and method that uses unique biometric signatures to provide an objective measure of pain and analgesic effectBackgroundThe overall prevalence of pain in the United States is substantial withof the adult population experiencing chronic painMoreoverthe rates of chronic pain are expected to continue to rise over timeconsequently adding to the overall health and economic burden on the populationWith pain being recognized as the upstream driver of the opioid epidemicadequately addressing pain and its management will not only mitigate the burden of pain but also contribute to preventing the problems associated with the opioid epidemicUnder the current standard of carepain assessment is subjective and predicated on a linear intensity scaleIt does not reflect the complexity of pain and does little to guide interventions best suited to an individual patient s pain profileThis application describes the development of a novel platform technology that produces an objective measure of pain which can guide analgesic interventionsThe TechnologyThe AlgometRx device is a platform technology that utilizes proprietary algorithms to provide an objective measure of pain and analgesic effectThe measurement of the pupillary response to low intensitynon noxious neuro specific neurostimulation serves as a biometric that reflects nociceptive processesThe derived pain phenotype reflects the impact of any genetic or environmental modulators of pain sensitivity or analgesic efficacy and reflects a personalized evaluation at the time of the assessmentObservations of pain and drug effect using biometric measures eliminate the subjective nature of pain managementExperimental ApproachThis proposal includes two studies using the research prototype to characterize different populations of pain and analgesic effects in a clinical settingThe first study will investigate acute pain patients undergoing opioid therapyThe second study will investigate chronic pain patients who receive other forms of analgesics as well as opioidsThe data generated from these studies will inform the ongoing development of algorithms to generate a pain phenotype that informs upon the type of painthe intervention necessary to mitigate the painand ongoing monitoring of the interventionAimsTo develop a methodology for the use of the PRD induced by non noxiousneurospecific neurostimulationn PRDas an objective measure of pain intensity and sensitivityTo determine the impact of analgesics on the n PRDTo assess acceptability and feasibility of the technology Burden of Pain as a Public Health Crisis in the United StatesMore thanmillion Americans suffer from chronic pain at an overall cost of around $billion per yearThe use of subjective pain scores limits pain assessment to a linear intensity scalewhich does not reflect the complex nature of pain and does little to discern the various elements that come to bear on one s perception of painAn objective measure of nociceptive processing would allow for a more precise understanding of a patient s pain and inform a targeted application of an interventionsuch as opioids