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Recruiting Observational

Neurosurgical Outcome Network

NCT06724029 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-12-05
Last updated
2026-03-30

Condition(s) studied

AneurysmsArteriovenous MalformationsCavernomasSkull Base TumorsMoyamoya DiseaseDural FistulasSubdural HematomaExtradural HematomaSubarachnoid HemorrhageHydrocephalusParkinson&Amp;#39;s DiseaseSpasticityTrigeminal NeuralgiaCraniofacial PainNeuropathic PainTremorDystoniasObsessive-compulsive DisorderDrug-resistant EpilepsyDepressionNormal Pressure HydrocephalusTumors of Peripheral NervesChiari Malformation Type 1

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Collect data — 5 years
    Collect and describe the pre- and postoperative clinical status in various neurosurgical pathologies.
  • Collection data — 5 years
    Collect and describe the pre- and postoperative cognitive status in various neurosurgical pathologies.
  • Collection data — 5 years
    Collect and describe the pre- and postoperative psychological status in various neurosurgical pathologies.

Trial sites (27)

FacilityCityRegionStatus
1. ASST Papa Giovanni XXIII Bergamo BG Active Not Recruiting
Spedali Civili Brescia Brescia BS Active Not Recruiting
Fondazione Poliambulanza Istituto Ospedaliero Brescia BS Active Not Recruiting
Ospedale Moriggia Pelascini Gravedona Como Active Not Recruiting
ASST Lariana, Ospedale S. Anna Como CO Active Not Recruiting
ASST Cremona Cremona CR Active Not Recruiting
Fondazione IRCCS San Gerardo dei Tintori Monza MB Active Not Recruiting
Fondazione IRCCS Policlinico San Matteo Pavia PV Active Not Recruiting
ASST della Valtellina ed Alto Lario Sondrio SO 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 Italy Recruiting
Ospedale Alessandro Manzoni Lecco Italy Active Not Recruiting
ASST Ovest Milanese Legnano Italy Active Not Recruiting
Ospedali Riuniti di Livorno -Azienda USL Toscana nord ovest Livorno Italy Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy Active Not Recruiting
ASST Santi Paolo e Carlo Milan Italy Recruiting
ASST Fatebenefratelli Sacco Milan Italy Active Not Recruiting
Istituto Clinico Città Studi Milan Italy Active Not Recruiting
Policlinico di Monza Monza Italy Recruiting
A.R.N.A.S. Ospedali Civico di Palermo Palermo Italy Recruiting
Azienda Ospedaliero Universitaria di Parma Parma Italy Active Not Recruiting
ASL Roma 1 Roma Italy Recruiting
Fondazione Policlinico Universitario Gemelli di Roma Roma Italy Recruiting
IRCCS Istituto Clinico Humanitas Rozzano Italy Active Not Recruiting
Azienda Sanitaria Universitaria Friuli Centrale di Udine Udine Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06724029 on ClinicalTrials.gov ↗ ← All trials in Italy