Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

Project SummaryAbstract Chronic pain affects overmillion Americans representing a major public health imperativeObjective biomarkers of pathology exist for several diseasesand their development is one of the great advances of modern allopathic medicinehoweverobjective assessment of pain has lagged far behindCurrentlythere are no objectively verifiable and clinically useful means to identify or quantify the presence or severity of painThe current standard of care relies on patient self reportsuch as the visual analog scaleVASwhich presents a serious barrier to the effective assessment and treatment of painSelf reported pain is influenced by nociceptiveaffectiveand cognitive processesand though many treatments effect reported painthey likely do so through a varied set of neurophysiological mechanismswith different consequences for health and long term well beingSome patients have difficulty assigning themselves a pain ratingespecially those with pain that falls towards the middle of the rating scaleIn additioncommunications issuesdrug seeking behaviorthe desire of some patients to appear stoicand other issues can create problems with establishing an accurate pain ratingAs a resultdespite a long history of researchcurrent assessment and treatment of pain is not optimalwith enormous costs to patients and societyPainQx is currently developing the PQX MED systema system that will objectively evaluate an individual s pain level using quantitative EEGQEEGAdvanced signal processingmachine learningclassification methodologies and a large reference database will be used to develop algorithms that quantify features of an individual s EEG that are associated with the perception of painBefore the PainQx platform is ready for its FDA Validation StudyPainQx needs to demonstrate the ability to assess pain in a representative set of patients with chronic painTo ensure commercial viabilityPainQx also needs to be able to generate its pain biomarker using a limited montage of EEG electrodes which can be rapidly applied prior to data acquisition and processingPainQx proposes to achieve these objectives through the proposed SBIR projectIn Phase IPainQx will conduct a clinical study ofchronic pain patients utilizinglead EEG acquisitionadd those cases to an existing database oflead pain casesand demonstrate thatLead EEG data can be used to assess the intensity of pain a patient is experiencingIn Phase IIPainQx will demonstrate that the relationship between the VAS and a QEEG based biomarker demonstrated usingleads can be demonstrated using a subset of EEG recording locations to significantly improve clinical utilityFurtherpredictive accuracy using the reduced montage will meet targets for performance established usinglead data Project Narrative The nature of self reported pain rating scales leads to difficulty in accurately identifyingevaluating and thereforeoptimally treating pain due to issues such as patient communication difficultiesdrug seeking behaviordifferences in pain toleranceand other challengesAs a resultpatients can be either over treatedleading toor perpetuatingaddiction as manifested by the opioid epidemicor under treatedleading to readmissionslost productivityunnecessary pain and sufferingand significant costs to the healthcare systemBy providing physicians an objective pain measurement toolPainQx believes it will allow physicians to increase certainty in dosing and treatment selectionthereby addressing the over and under treatment paradigmand consequently reducing opioid abuse and overall healthcare costs