Clinical trial · Interventional
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
| Epilepsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WISE Cortical Strip | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Investigational and Comparator devices
- description
- Investigational (WISE Cortical Strip, WCS) and comparator (Subdural Strip Electrode, Ad-Tech Medical Instruments Corporation) devices will be used together.
- interventionNames
- Device: WISE Cortical Strip
Primary outcomes (2)
- measure
- Serious Adverse Device Effects (SADEs) of the WISE Cortical Strip.
- timeFrame
- For the entire duration of the surgeries and after 24 hours
- measure
- The Signal-to-Noise Ratio percentage (SNR%) calculated on Somatosensory Evoked Potential (SEP) signals.
- timeFrame
- During the surgery
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDFedele 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
- BACKGROUNDKim 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
- BACKGROUNDMacdonald 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
- BACKGROUNDAungaroon 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