Neurosurgical Outcome Network

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06724029
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

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

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Aneurysms, Arteriovenous Malformations, Cavernomas, Skull Base Tumors, Moyamoya Disease, Dural Fistulas, Subdural Hematoma, Extradural Hematoma, Subarachnoid Hemorrhage, Hydrocephalus, Parkinson's Disease, Spasticity, Trigeminal Neuralgia, Craniofacial Pain, Neuropathic Pain, Tremor, Dystonias, Obsessive-compulsive Disorder, Drug-resistant Epilepsy, Depression, Normal Pressure Hydrocephalus, Tumors of Peripheral Nerves, Chiari Malformation Type 1
Additional Details

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

1. ASST Papa Giovanni XXIII, Bergamo, BG, Italy

Status

Active, not recruiting

Address

1. ASST Papa Giovanni XXIII

Bergamo, BG, 24127

Spedali Civili Brescia, Brescia, BS, Italy

Status

Active, not recruiting

Address

Spedali Civili Brescia

Brescia, BS, 25123

Brescia, BS, Italy

Status

Active, not recruiting

Address

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, BS, 25124

Ospedale Moriggia Pelascini, Gravedona, Como, Italy

Status

Active, not recruiting

Address

Ospedale Moriggia Pelascini

Gravedona, Como, 22015

ASST Lariana, Ospedale S. Anna, Como, CO, Italy

Status

Active, not recruiting

Address

ASST Lariana, Ospedale S. Anna

Como, CO, 22100

ASST Cremona, Cremona, CR, Italy

Status

Active, not recruiting

Address

ASST Cremona

Cremona, CR, 26100

Fondazione IRCCS San Gerardo dei Tintori, Monza, MB, Italy

Status

Active, not recruiting

Address

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900

Fondazione IRCCS Policlinico San Matteo, Pavia, PV, Italy

Status

Active, not recruiting

Address

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100

ASST della Valtellina ed Alto Lario, Sondrio, SO, Italy

Status

Active, not recruiting

Address

ASST della Valtellina ed Alto Lario

Sondrio, SO, 23100

Catania, Italy

Status

Recruiting

Address

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

Catania, ,

Site Contact

Giuseppe Barbagallo, MD

[email protected]

095 - 479 4473

Firenze, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Careggi

Firenze, ,

Site Contact

Alessandro Della Puppa, MD

[email protected]

055 794 8327

Ospedale F. Spaziani di Frosinone, Frosinone, Italy

Status

Recruiting

Address

Ospedale F. Spaziani di Frosinone

Frosinone, , 03100

Site Contact

Giancarlo D'Andrea, MD

[email protected]

07751802907

Ospedale Alessandro Manzoni, Lecco, Italy

Status

Active, not recruiting

Address

Ospedale Alessandro Manzoni

Lecco, , 23900

ASST Ovest Milanese, Legnano, Italy

Status

Active, not recruiting

Address

ASST Ovest Milanese

Legnano, , 20025

Livorno, Italy

Status

Recruiting

Address

Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest

Livorno, ,

Site Contact

Gianluca Grimod, MD

[email protected]

0586/223111

Milano, Italy

Status

Active, not recruiting

Address

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, , 20122

ASST Santi Paolo e Carlo, Milano, Italy

Status

Recruiting

Address

ASST Santi Paolo e Carlo

Milano, , 20153

Site Contact

Marcello Egidi, MD

[email protected]

02 4022 2079

ASST Fatebenefratelli Sacco, Milano, Italy

Status

Active, not recruiting

Address

ASST Fatebenefratelli Sacco

Milano, ,

Istituto Clinico Città Studi, Milano, Italy

Status

Active, not recruiting

Address

Istituto Clinico Città Studi

Milano, ,

Milan, Italy

Status

Recruiting

Address

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, , 20133

Site Contact

Paolo Ferroli, MD

[email protected]

+39 02 2394 2411 #2411

Policlinico di Monza, Monza, Italy

Status

Recruiting

Address

Policlinico di Monza

Monza, , 20900

Site Contact

Michele Incerti, MD

[email protected]

3662357286

A.R.N.A.S. Ospedali Civico di Palermo, Palermo, Italy

Status

Recruiting

Address

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

Palermo, , 90127

Site Contact

Giovanni Tringali, MD

[email protected]

0916663179

Parma, Italy

Status

Active, not recruiting

Address

Azienda Ospedaliero Universitaria di Parma

Parma, ,

ASL Roma 1, Roma, Italy

Status

Recruiting

Address

ASL Roma 1

Roma, , 00135

Site Contact

Flavia Fraschetti, MD

[email protected]

+39 06 6010.2350

Roma, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario Gemelli di Roma

Roma, , 00168

Site Contact

Massimiliano Visocchi, MD

[email protected]

06 3015 4408

IRCCS Istituto Clinico Humanitas, Rozzano, Italy

Status

Active, not recruiting

Address

IRCCS Istituto Clinico Humanitas

Rozzano, , 20089

Udine, Italy

Status

Recruiting

Address

Azienda Sanitaria Universitaria Friuli Centrale di Udine

Udine, , 33100

Site Contact

Marco Vindigni, MD

[email protected]

0432552701

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