New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms

NCT03152201 — Completed, 30 participants, Luca Valci

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I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali

Registry	NCT03152201
Status	Completed
Study type	Observational
Enrollment	30 (Actual)
Sponsor	Luca Valci (Other)
Conditions	Cerebral Aneurysm
Interventions	electrophysiological signal (Diagnostic test)
Dates	start 2017-05-03, primary completion 2021-11-04, completion 2021-11-04, first posted 2017-05-12, last updated 2022-08-16
Locations	1 site in Switzerland

-Summary

During surgery, electrophysiological signals will be acquired with the instrument (ISIS IOM, NeuroExplore, Software Version 4.4, Inomed) already in use at the Neurosurgery Service of the Neurocentro of the Hospital Civic Italian Switzerland in Lugano. Simultaneously to Somatosensorial Evoked Potential (SEP) will also be recorded the Electroencephalography (EEG) activity with the same detection of locations.

For the purposes of the study the signals transmitted to the neurosurgeon through the hardware and the corresponding assessments done by the neurophysiologist responsible for intraoperative monitoring will be recorded. It will also be kept track of procedures performed during surgery.

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+Arms and interventions

electrophysiological signal (Diagnostic test): trasmit the electrophysiological signals to the neurosurgeon through the hardware

+Outcome measures

Primary outcomes

hardware performance [at the moment of the surgery]: Collection of information on the hardware performance for reading and interpretation of the SEP and EEG signal and sending an alarm in visual form (light signal) in the eyepiece of the operating microscope during cerebral aneurysm interventions
Identification of sensitive electrophysiological index sensible to cerebral ischemic suffering [up to 3 months]: study of the morphology and the analysis of the high frequency of the SEP signal

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥ 18 years old
* Patient bearer of a not broken cerebral aneurysm, which has been defined per size and morphology susceptible to surgery
* Aneurysms located on cerebral arteries of the anterior circulation (carotid, middle cerebral arteries, anterior cerebral, anterior communicating, pericallose); Cases of multiple aneurysms are also eligible
* Informed consent for participation in the study

Exclusion Criteria:

* Patient with an aneurysm of the posterior circulation (vertebrobasilar system)
* The aneurysm was a source of bleeding (subarachnoid hemorrhage, intracerebral, intraventricular).
* Patient with a pace-maker (for the risk that the electric currents used in the study could compromise the operation of the pace-maker)

+Locations (1)

Facility	City	Country	Status
Neurocentro della Svizzera Italiana (NSI)	Lugano	Switzerland

+Investigators

Luca Valci, MD, Study chair, Ente Ospedaliero Cantonale, Bellinzona

My Notes

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