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

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Brief Title

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

Official Title

I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali

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.
    



Study Type

Observational


Primary Outcome

hardware performance


Condition

Cerebral Aneurysm

Intervention

electrophysiological signal


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

30

Start Date

May 3, 2017

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Luca Valci, MD, +41 91 811 6572, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT03152201

Organization ID

NCH-2017-01


Responsible Party

Sponsor-Investigator

Study Sponsor

Luca Valci


Study Sponsor

Luca Valci, MD, Study Chair, Ente Ospedaliero Cantonale, Bellinzona


Verification Date

March 2020