WISE Cortical Strip for Intraoperative Neurophysiological Monitoring (WIN)

Wise S.r.l.

Status: Completed

Conditions: Epilepsy; Brain Tumor Adult

Treatments: Device: WISE Cortical Strip

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03731455

001_WCS

Details and patient eligibility

About

The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the WISE Cortical Strip (WCS) for CE certification purposes. Participants with documented diagnosis of epilepsy or brain tumor requiring intracranial surgery, who meet all eligibility criteria, will undergo IntraOperative Neurophysiological Monitoring (IONM) during a neurosurgical intervention with the WCS and a comparator device.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. 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)
2. Age: 18 - 75 years at the time of enrollment
3. Required intraoperative neurophysiological monitoring with subdural electrodes
4. Willingness to provide informed consent for participating in the study

Exclusion critria:

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Investigational and Comparator devices

Experimental group

Description:

Investigational (WISE Cortical Strip, WCS) and comparator (Subdural Strip Electrode, Ad-Tech Medical Instruments Corporation) devices will be used together.

Treatment:

Device: WISE Cortical Strip