A Prospective, Interventional, Multi-center, Open-label, Premarket Study to Evaluate Safety, Performance and Usability of the Wise Cortical Strip for Intraoperative Neurophysiological Monitoring (WIN Study)

The IONM is the use of electrophysiological methods to identify important neural structures in the operative field, including eloquent areas, in order to monitor their functional integrity during the neurosurgical lesion resection. The benefit of performing functional monitoring of the areas surrounding the lesion is to minimize neurological damages during surgical lesions resection and thus to avoid and/or limit significant post-operative impairments. During the therapeutic resection of brain tumors or epileptogenic lesions, the use of the IONM is associated to other intraoperative techniques (e.g. brain mapping techniques) that, together to combined efforts of a multidisciplinary team of neurosurgeons, neuroradiologists, neuropsychologists, and neurophysiologists, contribute to the definition of location, extension, and extent of functional involvement that a lesion causes in an individual participant.

The principal electrophysiological methods to perform the IONM are the recording of brain's electrical activities (Somatosensory Evoked Potentials, SEPs and ElectroCorticoGraphy, ECoG) and electrical stimulation of motor regions (to elicit Motor Evoked Potentials, MEPs) using cortical strips placed on surface of the brain.

Thus, the WCS is intended to be used intraoperatively on the brain surface, to perform brain monitoring.