WISE Cortical Strip for Intraoperative Neurophysiological Monitoring

NCT03731455 | Completed DMC

• 1 other identifier: 001_WCS
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 5

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.

Conditions

Brain Tumor Adult; Epilepsy

Keywords

Cortical strip; Electrode

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Impedance values measured for the WISE Cortical Strip.

  During the surgery

• Motor Evoked Potentials (MEPs).

  During the surgery

• Dedicated usability questionnaire.

  Following surgeries

Study Arms (1)

Investigational and Comparator devices

EXPERIMENTAL

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

Device: WISE Cortical Strip

Interventions

WISE Cortical Strip DEVICE

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

Investigational and Comparator devices

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Wise S.r.l.: lead
• Genae: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (5)

Klinikum der Universitat München

Munich, Germany, 81377, Germany

Location

Azienda Ospedaliera Universitaria Integrata Verona (AOUI Verona)

Verona, Verona, 37126, Italy

Location

Inselspital

Bern, Switzerland, 3010, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland, 6000, Switzerland

Location

Universitätsspital

Zurich, Switzerland, 8091, Switzerland

Location

Related Publications (4)

• Fedele T, Schonenberger C, Curio G, Serra C, Krayenbuhl 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.

  PMID: 28826015 BACKGROUND

• 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.

  PMID: 24015028 BACKGROUND

• Macdonald DB. Intraoperative motor evoked potential monitoring: overview and update. J Clin Monit Comput. 2006 Oct;20(5):347-77. doi: 10.1007/s10877-006-9033-0. Epub 2006 Jul 11.

  PMID: 16832580 BACKGROUND

• 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.

  PMID: 28778475 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The neurosurgical intervention will be performed with both devices: investigational (Wise Cortical Strip, WCS) and comparator device.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 6, 2018
• Study Start: April 9, 2019
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (1); CH (3)