WISE Cortical Strip for Intraoperative Neurophysiological Monitoring

Epilepsy Clinical Trial

— WIN  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731455
• Other study ID #: 001_WCS
• Status: Completed
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: January 20, 2020

Study information

• Verified date: May 2021
• Source: Wise S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Related Conditions & MeSH terms

• Brain Tumor Adult
• Epilepsy

Intervention

Device:
• WISE Cortical Strip
The WISE Cortical Strip is a medical device composed by a strip and by a cable.

Locations

Country	Name	City	State
Germany	Klinikum der Universitat München	Munich
Italy	Azienda Ospedaliera Universitaria Integrata Verona (AOUI Verona)	Verona
Switzerland	Inselspital	Bern
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Universitätsspital	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
Wise S.r.l.	Fondazione Don Carlo Gnocchi Onlus, Genae

Countries where clinical trial is conducted

Germany,  Italy,  Switzerland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Device Effects (SADEs) of the WISE Cortical Strip.		For the entire duration of the surgeries and after 24 hours
Primary	The Signal-to-Noise Ratio percentage (SNR%) calculated on Somatosensory Evoked Potential (SEP) signals.		During the surgery
Secondary	Impedance values measured for the WISE Cortical Strip.		During the surgery
Secondary	Motor Evoked Potentials (MEPs).		During the surgery
Secondary	Dedicated usability questionnaire.		Following surgeries