Medasense Biometrics Ltd. (Medasense), a company for pain monitoring solutions, has scheduled to complete the trial called “A Single-Blind Randomized Clinical Trial to Assess the Efficacy of the Medasense's Non-Invasive Pain Monitor in Estimating the Pain Level Comparing to the Pain Stimuli and the Reported Pain Level on Healthy Subjects” for Pain Monitoring System by November 2009. The study is currently recruiting participants in Israel. The trial is designed to implement, validate performances of the pain monitoring device and also to evaluate the efficacy for automated pain level assessment in patients. The pain monitor efficacy will be tested by comparing its results to the patient pain reports towards a given pain stimuli.
The trial is estimated to enroll 100 healthy volunteers. They will be voluntarily inflicted by pain stimuli. The pain stimuli generally will be thermal heat pain stimulus and cold water pain stimulus which will be applied with different intensities. Plurality of Non-Invasive Physiological Measurements will be recorded from the subjects and their Numeric Pain Scale reports will be monitored before, during and after the pain induction. Also information such as age, gender, ethnicity, etc. will be collected. The collected database will be helpful to implement the algorithm that applies modern signal processing and machine learning methods in order to segregate between different pain levels. The algorithm will then be integrated into pain monitoring device.
Pain Monitoring System is a tool, which acquires in a non-invasive way, processes and uses multidimensional analysis of physiological signals to monitor the pain level. It uses a unique algorithms which analyzes large number of physiological signals that are collected from the patient via non-invasive sensors. It depends on multidimensional viewing of numerous isolated, but continuous numerical and string signals that are related to the patient conditions.