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

I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Aneurysm
• Intervention / Treatment: Diagnostic test: electrophysiological signal

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Switzerland
  • Lugano, Switzerland, 6903
    • Neurocentro della Svizzera Italiana (NSI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient bearer of a not broken cerebral aneurysm

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hardware performance	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	at the moment of the surgery
Identification of sensitive electrophysiological index sensible to cerebral ischemic suffering	study of the morphology and the analysis of the high frequency of the SEP signal	up to 3 months

Collaborators and Investigators

• Sponsor: Luca Valci
• Investigators: Study Chair: Luca Valci, MD, Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2017
• Primary Completion (ACTUAL): November 4, 2021
• Study Completion (ACTUAL): November 4, 2021

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (ACTUAL): May 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: NCH-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No