Cerebral AneurysmNCT03152201
New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms
An observational study of Cerebral Aneurysm, run by Luca Valci at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- electrophysiological signal
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 May 2017to 4 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient bearer of a not broken cerebral aneurysm
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali
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
- Being tested
- electrophysiological signal
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrophysiological signalDiagnostic test
trasmit the electrophysiological signals to the neurosurgeon through the hardware
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start3 May 2017
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luca Valci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luca Valci, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Luca Valci, MD, Study chair, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152201
- Sponsor's protocol ID
- NCH-2017-01
- Status last verified
- Aug 2022
- First submitted
- 4 May 2017
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali
- ClinicalTrials.gov ID
- NCT03152201
- Acronym / sponsor ID
- NCH-2017-01
- Conditions
- Cerebral Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Luca ValciUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient bearer of a not broken cerebral aneurysm
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrophysiological signaltrasmit the electrophysiological signals to the neurosurgeon through the hardware | Diagnostic test | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Valci, MD study chair
Ente Ospedaliero Cantonale, Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Aneurysm, run by Luca Valci at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hardware performance (time frame: at the moment of the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.