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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03152201
Other study ID # NCH-2017-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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