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

Cerebral Aneurysm Clinical Trial

Official title:

I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152201
• Other study ID #: NCH-2017-01
• Status: Completed
• Start date: May 3, 2017
• Est. completion date: November 4, 2021

Study information

• Verified date: August 2022
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

Diagnostic Test:
• electrophysiological signal
trasmit the electrophysiological signals to the neurosurgeon through the hardware

Locations

Country	Name	City	State
Switzerland	Neurocentro della Svizzera Italiana (NSI)	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Luca Valci

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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