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

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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Key information

Conditions

Cerebral Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurocentro della Svizzera Italiana (NSI)

Lugano, 6903, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

electrophysiological signal

Diagnostic Test

trasmit the electrophysiological signals to the neurosurgeon through the hardware

Primary outcomes

hardware performance

Time frame: 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

Time frame: up to 3 months

study of the morphology and the analysis of the high frequency of the SEP signal

Sponsors and collaborators

Lead sponsor

Luca Valci

Other

Registry information

Official study title

I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: May 12, 2017
Registry last updated: Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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