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AzTrials

AneurysmsNEONNCT06724029

Neurosurgical Outcome Network

An observational study of Aneurysms and Arteriovenous Malformations, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 27 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The evaluation of neurosurgical outcomes varies from center to center, and the predictive factors that determine these outcomes are not fully known or shared. This study aims to assess outcomes and their predictors using measures agreed upon by the participating centers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aneurysms, Arteriovenous Malformations, Cavernomas
How many people
4,500 participants
Where
27 sitesItaly
Study dates
5 Dec 2022to Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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: Patients older than 18 years old, with neurosurgical pathology

Who may be able to join

  • Neuro-oncological pathology: supratentorial and subtentorial tumors, intra and extra axial tumors excluding the skull base (anterior, middle and posterior fossa; sellar and parasellar region)
  • Basicranial pathology: tumors originating from the anterior cranial fossa, middle cranial fossa and posterior cranial fossa, sellar region with or without supratentorial/parasellar development.
  • Vascular pathology: aneurysms, AVMs, cavernomas, other pathologies (Moyamoya disease, dural fistulas, nontraumatic hematomas)
  • Traumatic pathology: diffuse damage (nonvisible diffuse damage, diffuse damage, diffuse damage with edema, diffuse damage with shift) and focal damage (acute/subacute/chronic subdural hematoma, extradural hematoma, subarachnoid hemorrhage, intraparenchymal hematoma, fractures); hydrocephalus. The inclusion criterion for chronic subdural hematoma is recent bleeding for TBI with CT finding of chronic subdural hematoma candidate for evacuation surgery.
  • Spinal pathology: degenerative cervical (anterior/posterior), myelopathic, and trauma pathology; instrumented, uninstrumented thoracolumbar pathology (disc pathology, canal pathology), and trauma pathology; oncologic spinal pathology.
  • Functional pathology: Parkinson's disease, spasticity, trigeminal neuralgia, craniofacial pain/algia, neuropathic pain, tremor, dystonias, obsessive compulsive disorder, drug-resistant epilepsies, depression. Normotensive hydrocephalus.
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  • Peripheral nervous system pathology: peripheral nerve compression syndromes, peripheral nerve and plexus tumors, brachial plexus and peripheral nerve trauma (contusion and section)
  • Malformative pathology: Chiari malformation type 1 and craniostenoses including both those framed in malformative syndromes and those not framed in malformative syndromes (monosutural craniostenoses: trigonocephaly, plagiocephaly, scaphocephaly; multisutural craniostenoses). Malformative hydrocephalus.
  • For cognitive and psychological assessment: age 18 years or older; adequate understanding of Italian language; diagnosis of glioma, meningioma, vascular pathology, spinal pathology

Who cannot join

  • For cognitive and psychological assessment: patients with psychiatric diseases in history and/or taking psychotropic drugs; presence of overt cognitive decline (not due to the injury) in history; patients younger than 18 years old.

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Paolo Ferroli, MD contact

+39 02 2394 2411 ext. 2411

paolo.ferroli@istituto-besta.it

Morgan A Broggi, MD contact

+39 02 2394 2411 ext. 2411

morgan.broggi@istituto-besta.it

27 sites in 1 country

Italy27 sites, 11 recruiting

  • 1. ASST Papa Giovanni XXIII

    Bergamo, BG, 24127

    Active, not recruiting

  • Spedali Civili Brescia

    Brescia, BS, 25123

    Active, not recruiting

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, BS, 25124

    Active, not recruiting

  • Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"

    Catania

    Giuseppe Barbagallo, MD, 095 - 479 4473, giuseppebarbagal@hotmail.com

    Giuseppe Barbagallo, MD

    Recruiting

  • ASST Lariana, Ospedale S. Anna

    Como, CO, 22100

    Active, not recruiting

  • ASST Cremona

    Cremona, CR, 26100

    Active, not recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Florence

    Alessandro Della Puppa, MD, 055 794 8327, alessandro.dellapuppa@unifi.it

    Alessandro Della Puppa, MD

    Recruiting

  • Ospedale F. Spaziani di Frosinone

    Frosinone, 03100

    Giancarlo D'Andrea, MD, 07751802907, giancarlo.dandrea@aslfrosinone.it

    Giancarlo D'Andrea, MD

    Recruiting

  • Ospedale Moriggia Pelascini

    Gravedona, Como, 22015

    Active, not recruiting

  • Ospedale Alessandro Manzoni

    Lecco, 23900

    Active, not recruiting

  • ASST Ovest Milanese

    Legnano, 20025

    Active, not recruiting

  • Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest

    Livorno

    Gianluca Grimod, MD, 0586/223111, gianluca.grimod@uslnordovest.toscana.it

    Gianluca Grimod, MD

    Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

    Paolo Ferroli, MD, +39 02 2394 2411 ext. 2411, paolo.ferroli@istituto-besta.it

    Morgan A Broggi, MD, + 39 2394 2411 ext. 2411, morgan.broggi@istituto-besta.it

    Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Active, not recruiting

  • ASST Santi Paolo e Carlo

    Milan, 20153

    Marcello Egidi, MD, 02 4022 2079, marcello.egidi@asst-santipaolocarlo.it

    Marcello Egidi, MD

    Recruiting

  • ASST Fatebenefratelli Sacco

    Milan

    Active, not recruiting

  • Istituto Clinico Città Studi

    Milan

    Active, not recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, MB, 20900

    Active, not recruiting

  • Policlinico di Monza

    Monza, 20900

    Michele Incerti, MD, 3662357286, micheleincerti@libero.it

    Michele Incerti, MD

    Recruiting

  • A.R.N.A.S. Ospedali Civico di Palermo

    Palermo, 90127

    Giovanni Tringali, MD, 0916663179, giovanni.tringali@arnascivico.it

    Giovanni Tringali, MD

    Recruiting

  • Azienda Ospedaliero Universitaria di Parma

    Parma

    Active, not recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, PV, 27100

    Active, not recruiting

  • ASL Roma 1

    Roma, 00135

    Flavia Fraschetti, MD, +39 06 6010.2350, flavia.fraschetti@gmail.com

    Flavia Fraschetti, MD

    Recruiting

  • Fondazione Policlinico Universitario Gemelli di Roma

    Roma, 00168

    Massimiliano Visocchi, MD, 06 3015 4408, massimiliano.visocchi@policlinicogemelli.it

    Massimiliano Visocchi, MD

    Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

    Active, not recruiting

  • ASST della Valtellina ed Alto Lario

    Sondrio, SO, 23100

    Active, not recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale di Udine

    Udine, 33100

    Marco Vindigni, MD, 0432552701, marco.vindigni@asufc.sanita.fvg.it

    Marco Vindigni, MD

    Recruiting

Other trials in Italy

About this study

Official title: Neurosurgical Outcome Network Per la Predizione Dell'Outcome in Neurochirurgia

The evaluation of neurosurgical outcomes varies from center to center, and the predictive factors that determine these outcomes are not fully known or shared. This study aims to assess outcomes and their predictors using measures agreed upon by the participating centers. Standardizing the evaluation of outcomes and predictors improves the quality of research, allows for data comparison, and facilitates a "common language" in routine clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical conditions. Clinically, the identified predictors can also be used during preoperative assessments to provide more precise guidance to patients undergoing surgery.

Read the detailed description

The evaluation of outcome indicators, quality of life, and complexity in Neurosurgery has gained significant importance not only at a clinical and therapeutic level but also as a tool to assess the effectiveness and efficiency of the healthcare system. This study aims to evaluate neurosurgical outcomes and their predictors using measures shared among participating centers. Such evaluation varies from center to center, and the predictive factors are not entirely known or shared. Standardizing the evaluation of outcomes and predictors improves research quality, enables data comparison, and fosters a common language in everyday clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical pathologies.

Primary Objective: Collect and describe the pre- and postoperative clinical, cognitive, and psychological status in various neurosurgical pathologies.

Secondary Objectives: Identify outcome predictors. Primary Endpoint: Description of pre- and postoperative clinical, cognitive, and psychological data of patients undergoing neurosurgical intervention.

Secondary Endpoints: Analyze the association between preoperative indicators collected and postoperative outcomes. Specific predictors and outcome measures for each neurosurgical pathology will be considered and reported in Appendix 1. Patient enrollment from Neurosurgery Departments; collection of clinical, cognitive, and psychological data before the intervention and during follow-up after the intervention (timing varies depending on the neurosurgical pathology); data analysis through AI. For all neurosurgical pathologies, the following data will be collected: sociodemographic, clinical (Charlson Comorbidity Index, heart disease, diabetes, Chronic Obstructive Pulmonary Disease, hypertension, Body Mass Index, smoking, psychiatric pathology, admission date, intervention date, discharge date, Modified Rankin Scale, American Society of Anesthesiologists, weight, height), anesthesiological (collected only by FINCB), and complication-related data (Novel Therapy-Disability-Neurology).

Keywords
Neurosurgery Outcome Artificial Intelligence predictors
Medical subject headings
Aneurysm, Arteriovenous Malformations, Moyamoya Disease, Hematoma, Subdural, Hematoma, Epidural, Spinal, Subarachnoid Hemorrhage, Hydrocephalus, Muscle Spasticity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Collect data

    Collect and describe the pre- and postoperative clinical status in various neurosurgical pathologies.

    Measured: 5 years

  2. Collection data

    Collect and describe the pre- and postoperative cognitive status in various neurosurgical pathologies.

    Measured: 5 years

  3. Collection data

    Collect and describe the pre- and postoperative psychological status in various neurosurgical pathologies.

    Measured: 5 years

Secondary outcomes (1)

  1. Identify Predictors

    Identify outcome predictors.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2024
  2. Study start5 Dec 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
4,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06724029
Sponsor's protocol ID
NEON
Acronym
NEON
Status last verified
Mar 2026
First submitted
2 Dec 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Terrapon APR, Zattra CM, Voglis S, Velz J, Vasella F, Akeret K, Held U, Schiavolin S, Bozinov O, Ferroli P, Broggi M, Sarnthein J, Regli L, Neidert MC. Adverse Events in Neurosurgery: The Novel Therapy-Disability-Neurology Grade. Neurosurgery. 2021 Jul 15;89(2):236-245. doi: 10.1093/neuros/nyab121.

    PubMed 33887774

  • RANKIN J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957 May;2(5):200-15. doi: 10.1177/003693305700200504. No abstract available.

    PubMed 13432835

  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PubMed 3558716

  • Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012 Jun;9(3):322-9. doi: 10.1177/1740774512438980. Epub 2012 Feb 27.

    PubMed 22371630

  • Jakola AS, Unsgard G, Solheim O. Quality of life in patients with intracranial gliomas: the impact of modern image-guided surgery. J Neurosurg. 2011 Jun;114(6):1622-30. doi: 10.3171/2011.1.JNS101657. Epub 2011 Feb 11.

    PubMed 21314270

  • Sagberg LM, Drewes C, Jakola AS, Solheim O. Accuracy of operating neurosurgeons' prediction of functional levels after intracranial tumor surgery. J Neurosurg. 2017 Apr;126(4):1173-1180. doi: 10.3171/2016.3.JNS152927. Epub 2016 Jun 17.

    PubMed 27315026

  • Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013 Aug 4;6:61-8. doi: 10.4137/HSI.S11093. eCollection 2013.

    PubMed 25114561

  • Tomlinson SB, Piper K, Kimmell KT, Vates GE. Preoperative Frailty Score for 30-Day Morbidity and Mortality After Cranial Neurosurgery. World Neurosurg. 2017 Nov;107:959-965. doi: 10.1016/j.wneu.2017.07.081. Epub 2017 Jul 20.

    PubMed 28736345

  • Reponen E, Tuominen H, Korja M. Evidence for the use of preoperative risk assessment scores in elective cranial neurosurgery: a systematic review of the literature. Anesth Analg. 2014 Aug;119(2):420-432. doi: 10.1213/ANE.0000000000000234.

    PubMed 25046789

Questions about this trial

What is this clinical trial studying?

An observational study of Aneurysms and Arteriovenous Malformations, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 27 sites in Italy.

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 9 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paolo Ferroli, MD (+39 02 2394 2411 ext. 2411, paolo.ferroli@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collect data (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06724029, which also lists 9 linked publications.

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 30 Mar 2026.

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