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

NCT03152201 | Completed

• 1 other identifier: NCH-2017-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

electrophysiological signal DIAGNOSTIC_TEST

trasmit the electrophysiological signals to the neurosurgeon through the hardware

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient bearer of a not broken cerebral aneurysm

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Luca Valci: lead

Study Sites (1)

Neurocentro della Svizzera Italiana (NSI)

Lugano, 6903, Switzerland

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Luca Valci, MD

  Ente Ospedaliero Cantonale, Bellinzona

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 12, 2017
• Study Start: May 3, 2017
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)