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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-03

Study Completion Date

2021-11-04

Brief Summary

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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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Detailed Description

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Conditions

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Cerebral Aneurysm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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electrophysiological signal

trasmit the electrophysiological signals to the neurosurgeon through the hardware

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No