Expected completion: 01/10/2018
With the improvement of neurological intensive care, an increasing number of patients survive after acute brain injury. Most of the survivors undergo an altered state of consciousness with impaired reactivity to external stimuli referred to as coma. As such, there is a growing demand for improving the monitoring of the extent of brain injury during coma as well as to predict the outcome upon awakening. Research carried out by Termobit Prod SRL during the last 5 years in collaboration with university partners from Romania and prestigious international universities such as Harvard USA, Oxford UK, Copenhagen, DK and Toronto, CA provided the scientific foundation for an entirely new principle of coma monitoring referred to as neurophysiological reactivity. Furthermore, we established the hardware /software for a technological proof-of-concept for monitoring the electroencephalographic (EEG) reactivity to photic and electrical stimuli during the deepest levels of coma, referred to a burst-suppression. These results encourage us to take the step forward and transfer this concept into a technology readiness level 6 prototype for a neurophysiological reactivity monitor (NERMO) applicable in all levels of coma, which greatly increases its addressability. The increased complexity in lighter coma states monitoring requires 1) scaling of the EEG amplifier to 32 channels, 2) addition of a vocal stimulus modality to test the reactivity to subjects-own-name and 3) integrating EEG reactivity measures with heart-rate variability measures of arousal. The prototype, designed by medical device standards, will be validated both in animal experiments and the clinical setting in collaboration with our Romanian partners. The data in different altered states of consciousness collected in these studies will provide a valuable normative database essential for coma outcome prediction. As such we will ensure that NERMO will become of interest as both a research and a clinical device.
Our previous studies indicate that by quantifying the perturbation in brains electrical activity (measured by a 6-channel EEG) in response to a simple sequence of photic/electric stimuli, we could derive a measure of reactivity that can be used to assess patients in deep comatose states. This project aims to expand this principle into a prototype neurophysiological reactivity monitor (NERMO) that could be used to assess a broad spectrum of altered states of consciousness. For this, we aim to: 1) scale the acquisition hardware to allow recording of a 32-channel EEG for an improved topographic resolution; 2) develop an auditory simulation system capable of generating complex vocal stimuli (e.g. subject’s own name); 3) record heart rate variability (from ECG) to integrate measures of autonomic nervous system reactivity. The derived neurophysiological reactivity index will be validated in clinical and experimental studies.
We expect to achieve a NERMO prototype device, at TRL 6, which, by integrating EEG and ECG perturbations to multimodal stimuli of different complexities, will be used to clinically asses a broad spectrum of altered states of consciousness/depth of coma. As such, NERMO will be designed in compliance with quality standards applicable to medical devices. The resulted technology will be patented in order to support further development and monetization, and the scientific results will be published in peer-reviewed journals.