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

I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03152201

Enrollment

Registered

2017-05-12

Start date

2017-05-03

Completion date

2021-11-04

Last updated

2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Aneurysm

Brief 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.

Interventions

DIAGNOSTIC_TESTelectrophysiological signal

trasmit the electrophysiological signals to the neurosurgeon through the hardware

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026