Neurosurgical Outcome Network

NCT06724029 | Recruiting

• 1 other identifier: NEON
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 27

Brief 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. 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.

Conditions

Aneurysms; Arteriovenous Malformations; Cavernomas; Skull Base Tumors; Moyamoya Disease; Dural Fistulas; Subdural Hematoma; Extradural Hematoma; Subarachnoid Hemorrhage; Hydrocephalus; Parkinson&Amp;#39;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

Keywords

Neurosurgery Outcome Artificial Intelligence predictors

Outcome Measures

Primary Outcomes (3)

• Collect data

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

  5 years

• Collection data

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

  5 years

• Collection data

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

  5 years

Secondary Outcomes (1)

• Identify Predictors

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients older than 18 years old, with neurosurgical pathology

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (27)

1. ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

ACTIVE NOT RECRUITING

Spedali Civili Brescia

Brescia, BS, 25123, Italy

ACTIVE NOT RECRUITING

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, BS, 25124, Italy

ACTIVE NOT RECRUITING

Ospedale Moriggia Pelascini

Gravedona, Como, 22015, Italy

ACTIVE NOT RECRUITING

ASST Lariana, Ospedale S. Anna

Como, CO, 22100, Italy

ACTIVE NOT RECRUITING

ASST Cremona

Cremona, CR, 26100, Italy

ACTIVE NOT RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

ACTIVE NOT RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

ACTIVE NOT RECRUITING

ASST della Valtellina ed Alto Lario

Sondrio, SO, 23100, Italy

ACTIVE NOT RECRUITING

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

Catania, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

RECRUITING

Ospedale F. Spaziani di Frosinone

Frosinone, 03100, Italy

RECRUITING

Ospedale Alessandro Manzoni

Lecco, 23900, Italy

ACTIVE NOT RECRUITING

ASST Ovest Milanese

Legnano, 20025, Italy

ACTIVE NOT RECRUITING

Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest

Livorno, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

ACTIVE NOT RECRUITING

ASST Santi Paolo e Carlo

Milan, 20153, Italy

RECRUITING

ASST Fatebenefratelli Sacco

Milan, Italy

ACTIVE NOT RECRUITING

Istituto Clinico Città Studi

Milan, Italy

ACTIVE NOT RECRUITING

Policlinico di Monza

Monza, 20900, Italy

RECRUITING

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

Palermo, 90127, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

ACTIVE NOT RECRUITING

ASL Roma 1

Roma, 00135, Italy

RECRUITING

Fondazione Policlinico Universitario Gemelli di Roma

Roma, 00168, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

ACTIVE NOT RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale di Udine

Udine, 33100, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 33887774 BACKGROUND

• 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.

  PMID: 13432835 BACKGROUND

• 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.

  PMID: 3558716 BACKGROUND

• 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.

  PMID: 22371630 BACKGROUND

• 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.

  PMID: 21314270 BACKGROUND

• 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.

  PMID: 27315026 BACKGROUND

• 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.

  PMID: 25114561 BACKGROUND

• 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.

  PMID: 28736345 BACKGROUND

• 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.

  PMID: 25046789 BACKGROUND

MeSH Terms

Conditions

Aneurysm; Arteriovenous Malformations; Moyamoya Disease; Hematoma, Subdural; Hematoma, Epidural, Spinal; Subarachnoid Hemorrhage; Hydrocephalus; Muscle Spasticity; Trigeminal Neuralgia; Facial Pain; Neuralgia; Tremor; Dystonic Disorders; Obsessive-Compulsive Disorder; Drug Resistant Epilepsy; Depression; Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Craniocerebral Trauma; Trauma, Nervous System; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases; Dyskinesias; Movement Disorders; Anxiety Disorders; Mental Disorders; Epilepsy; Behavioral Symptoms; Behavior

Central Study Contacts

Paolo Ferroli, MD

CONTACT

+39 02 2394 2411; paolo.ferroli@istituto-besta.it

Morgan A Broggi, MD

CONTACT

+39 02 2394 2411; morgan.broggi@istituto-besta.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 9, 2024
• Study Start: December 5, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (27)