Handheld Point of Care Electro-Diagnostic Device

Study Summary

There are currently several products offering POC EEG, intended to be deployed on each patient individually and continuously. The investigators propose studying a different approach by using a migrating POC electrodiagnostic device that is deployed directly by the onsite provider and is actively used, like other POC devices, to acquire real-time diagnostic insight and facilitate immediate medical decision making. This can significantly shorten time to treatment which in several neurological and neurosurgical conditions, and thus, can significantly improve patient outcome. The investigational POC investigational device is based on a handheld limited electrode array, complemented by various stimulation modalities such as SSEP, VEP and BAEP, and potentially other sensors. For this study, the investigators intend to use readily available industry standard stimulators and only use the proposed POC investigational device to acquire and analyze the data. The POC investigational electrodiagnostic prototype was assembled using OpenBCI8 electronic board and electrodes, based on ADS 129X chip by Texas Instruments, that was shown to provide an adequate low-cost solution for electrodiagnostic data acquisition.

Primary Outcome

The diagnostic insights acquired using the POC investigation device regarding lateralization (left/right), localization (cerebral - frontal, temporal, parieto-occipital; spinal - cervical, thoracal, lumbosacral; or radicular), and presumed nature of lesion (i.e. ischemia, hemorrhage, space-occupying lesion), are significantly comparable to, and congruent with, the SOC diagnostic insight regarding same parameters (lateralization, localization and presumed etiology) acquired using SOC techniques s

Conditions Studied

Interventions

• DIAGNOSTIC_TEST POC EEG

Study Locations (1)