WIN: WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational and Comparator devices Investigational (WISE Cortical Strip, WCS) and comparator (Subdural Strip Electrode, Ad-Tech Medical Instruments Corporation) devices will be used together. |
Device: WISE Cortical Strip
The WISE Cortical Strip is a medical device composed by a strip and by a cable.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Impedance values measured for the WISE Cortical Strip. [During the surgery]
- Motor Evoked Potentials (MEPs). [During the surgery]
- Dedicated usability questionnaire. [Following surgeries]
Eligibility Criteria
Criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum der Universitat München | Munich | Germany | 81377 | |
| 2 | Azienda Ospedaliera Universitaria Integrata Verona (AOUI Verona) | Verona | Italy | 37126 | |
| 3 | Inselspital | Bern | Switzerland | 3010 | |
| 4 | Luzerner Kantonsspital | Luzern | Switzerland | 6000 | |
| 5 | Universitätsspital | Zürich | Switzerland | 8091 |
Sponsors and Collaborators
- Wise S.r.l.
- Genae
- Fondazione Don Carlo Gnocchi Onlus
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Aungaroon G, Zea Vera A, Horn PS, Byars AW, Greiner HM, Tenney JR, Arthur TM, Crone NE, Holland KD, Mangano FT, Arya R. After-discharges and seizures during pediatric extra-operative electrical cortical stimulation functional brain mapping: Incidence, thresholds, and determinants. Clin Neurophysiol. 2017 Oct;128(10):2078-2086. doi: 10.1016/j.clinph.2017.06.259. Epub 2017 Jul 18.
- Fedele T, Schönenberger C, Curio G, Serra C, Krayenbühl N, Sarnthein J. Intraoperative subdural low-noise EEG recording of the high frequency oscillation in the somatosensory evoked potential. Clin Neurophysiol. 2017 Oct;128(10):1851-1857. doi: 10.1016/j.clinph.2017.07.400. Epub 2017 Jul 27.
- Kim SM, Kim SH, Seo DW, Lee KW. Intraoperative neurophysiologic monitoring: basic principles and recent update. J Korean Med Sci. 2013 Sep;28(9):1261-9. doi: 10.3346/jkms.2013.28.9.1261. Epub 2013 Aug 28. Review.
- Macdonald DB. Intraoperative motor evoked potential monitoring: overview and update. J Clin Monit Comput. 2006 Oct;20(5):347-77. Epub 2006 Jul 11. Review.
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