Neurosurgical Outcome Network (NEON)

March 25, 2026 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Study Overview

Status

Recruiting

Conditions

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).

Study Type

Observational

Enrollment (Estimated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
        • Contact:
        • Principal Investigator:
          • Giuseppe Barbagallo, MD
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi
        • Contact:
        • Principal Investigator:
          • Alessandro Della Puppa, MD
      • Frosinone, Italy, 03100
        • Recruiting
        • Ospedale F. Spaziani di Frosinone
        • Contact:
        • Principal Investigator:
          • Giancarlo D'Andrea, MD
      • Lecco, Italy, 23900
        • Active, not recruiting
        • Ospedale Alessandro Manzoni
      • Legnano, Italy, 20025
        • Active, not recruiting
        • Asst Ovest Milanese
      • Livorno, Italy
        • Recruiting
        • Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest
        • Contact:
        • Principal Investigator:
          • Gianluca Grimod, MD
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paolo Ferroli, MD
        • Sub-Investigator:
          • Morgan A Broggi, MD
      • Milan, Italy, 20122
        • Active, not recruiting
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20153
      • Milan, Italy
        • Active, not recruiting
        • Asst Fatebenefratelli Sacco
      • Milan, Italy
        • Active, not recruiting
        • Istituto Clinico Città Studi
      • Monza, Italy, 20900
        • Recruiting
        • Policlinico di Monza
        • Contact:
        • Principal Investigator:
          • Michele Incerti, MD
      • Palermo, Italy, 90127
        • Recruiting
        • A.R.N.A.S. Ospedali Civico di Palermo
        • Contact:
        • Principal Investigator:
          • Giovanni Tringali, MD
      • Parma, Italy
        • Active, not recruiting
        • Azienda Ospedaliero Universitaria di Parma
      • Roma, Italy, 00135
        • Recruiting
        • ASL Roma 1
        • Contact:
        • Principal Investigator:
          • Flavia Fraschetti, MD
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Gemelli di Roma
        • Contact:
        • Principal Investigator:
          • Massimiliano Visocchi, MD
      • Rozzano, Italy, 20089
        • Active, not recruiting
        • IRCCS Istituto Clinico Humanitas
      • Udine, Italy, 33100
        • Recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale di Udine
        • Contact:
        • Principal Investigator:
          • Marco Vindigni, MD
    • BG
      • Bergamo, BG, Italy, 24127
        • Active, not recruiting
        • 1. ASST Papa Giovanni XXIII
    • BS
      • Brescia, BS, Italy, 25123
        • Active, not recruiting
        • Spedali Civili Brescia
      • Brescia, BS, Italy, 25124
        • Active, not recruiting
        • Fondazione Poliambulanza Istituto Ospedaliero
    • CO
      • Como, CO, Italy, 22100
        • Active, not recruiting
        • ASST Lariana, Ospedale S. Anna
    • CR
      • Cremona, CR, Italy, 26100
        • Active, not recruiting
        • ASST Cremona
    • Como
      • Gravedona, Como, Italy, 22015
        • Active, not recruiting
        • Ospedale Moriggia Pelascini
    • MB
      • Monza, MB, Italy, 20900
        • Active, not recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
    • PV
      • Pavia, PV, Italy, 27100
        • Active, not recruiting
        • Fondazione IRCCS Policlinico San Matteo
    • SO
      • Sondrio, SO, Italy, 23100
        • Active, not recruiting
        • ASST della Valtellina ed Alto Lario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients older than 18 years old, with neurosurgical pathology

Description

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect data
Time Frame: 5 years
Collect and describe the pre- and postoperative clinical status in various neurosurgical pathologies.
5 years
Collection data
Time Frame: 5 years
Collect and describe the pre- and postoperative cognitive status in various neurosurgical pathologies.
5 years
Collection data
Time Frame: 5 years
Collect and describe the pre- and postoperative psychological status in various neurosurgical pathologies.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify Predictors
Time Frame: 1 year
Identify outcome predictors.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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