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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03152201
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Luca Valci, Ente Ospedaliero Cantonale, Bellinzona

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.


Condition or disease Intervention/treatment
Cerebral Aneurysm Diagnostic Test: electrophysiological signal

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms


Intervention Details:
  • Diagnostic Test: electrophysiological signal
    trasmit the electrophysiological signals to the neurosurgeon through the hardware


Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient bearer of a not broken cerebral aneurysm
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152201


Contacts
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Contact: Luca Valci, MD +41 91 811 6572 luca.valci@eoc.ch

Locations
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Switzerland
Neurocentro della Svizzera Italiana (NSI) Recruiting
Lugano, Switzerland, 6903
Contact: Luca Valci, Dr. med.    +41 91 811 6572    luca.valci@eoc.ch   
Sponsors and Collaborators
Luca Valci
Investigators
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Study Chair: Luca Valci, MD Ente Ospedaliero Cantonale, Bellinzona

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Responsible Party: Luca Valci, Dr. med., Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT03152201    
Other Study ID Numbers: NCH-2017-01
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases