A Wearable and Novel Algorithm for Objective Measurement of Chronic Pain

M. Orzabal
CereVu Medical, Texas, United States

Poster stand number: T139

Keywords: Wearable, Continuous, Real-time, Pain, objective

Chronic pain impacts 1 in five Americans and is difficult to manage, costing ~$600 billion annually. Of all active-duty service members, 31-44% are affected by chronic pain which leads to disability and reduced readiness. We have developed a small, low-cost forehead wearable and app that captures vital signs and a novel biomarker for objective, real-time and continuous pain assessment using proprietary algorithms and cerebral optical spectrometry. The algorithm was tested in patients who elected to receive an epidural steroid injection (ESI) for treatment of chronic pain. Subjects rated their pain on a numeric rating scale (NRS) ranging from 0-10. Multiple time points, including pre-, during and post-procedure were recorded. The ESI was performed per standard medical practice. Area under the receiver operator curves (AUC) for a majority of the subjects shows that the Vitality sensor can distinguish between clinically meaningful pain severity differentiations (no/mild –moderate –severe) with an accuracy of at least good (AUC: 70-79%) to excellent (AUC> 90%). Cerebral Optical Spectrometry based ROPA significantly correlated with subjectively reported pain in patients with chronic pain, and could be a useful monitor for clinical circumstances where direct assessment is not available, or to complement patient-reported pain scores.