Brain Tumor Adult, Epilepsy
Conditions
Keywords
Cortical strip, Electrode
Brief summary
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.
Detailed 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.
Interventions
DEVICEWISE Cortical Strip
The WISE Cortical Strip is a medical device composed by a strip and by a cable.
Sponsors
Genae
Fondazione Don Carlo Gnocchi Onlus
Wise S.r.l.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The neurosurgical intervention will be performed with both devices: investigational (Wise Cortical Strip, WCS) and comparator device.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious Adverse Device Effects (SADEs) of the WISE Cortical Strip. | For the entire duration of the surgeries and after 24 hours |
| The Signal-to-Noise Ratio percentage (SNR%) calculated on Somatosensory Evoked Potential (SEP) signals. | During the surgery |
Secondary
| Measure | Time frame |
|---|---|
| Impedance values measured for the WISE Cortical Strip. | During the surgery |
| Motor Evoked Potentials (MEPs). | During the surgery |
| Dedicated usability questionnaire. | Following surgeries |
Countries
Germany, Italy, Switzerland
Outcome results
None listed