WISE Cortical Strip for Intraoperative Neurophysiological Monitoring

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.

Inclusion criteria

• Brain tumor or epilepsy that require neurosurgical intervention and exposure of the central region of the cerebral cortex including at least the hand-forearm areas in the primary motor cortex and the primary somatosensory cortex (i.e. excision of lesion, open approach)
• Age: 18 - 75 years at the time of enrollment
• Required intraoperative neurophysiological monitoring with subdural electrodes
• Willingness to provide informed consent for participating in the study

Exclusion critria:

• Significant psychiatric impairments which, in the opinion of the investigator, will interfere with the proper administration or completion of the protocol
• Acute or untreated infections (viral, bacterial or fungal)
• Currently on any anticoagulant medication that cannot be discontinued during the perioperative period, or patients with factor XIII deficiency or any other hematological disease
• Current treatment with antibiotics